It is commonly hypothesized that scientists are more likely to engage in data falsification and fabrication when they are subject to pressures to publish, when they are not restrained by forms of social control, when they work in countries lacking policies to tackle scientific misconduct, and when they are male. Evidence to test these hypotheses, however, is inconclusive due to the difficulties of obtaining unbiased data. Here we report a pre-registered test of these four hypotheses, conducted on papers (...) that were identified in a previous study as containing problematic image duplications through a systematic screening of the journal PLoS ONE. Image duplications were classified into three categories based on their complexity, with category 1 being most likely to reflect unintentional error and category 3 being most likely to reflect intentional fabrication. We tested multiple parameters connected to the hypotheses above with a matched-control paradigm, by collecting two controls for each paper containing duplications. Category 1 duplications were mostly not associated with any of the parameters tested, as was predicted based on the assumption that these duplications were mostly not due to misconduct. Categories 2 and 3, however, exhibited numerous statistically significant associations. Results of univariable and multivariable analyses support the hypotheses that academic culture, peer control, cash-based publication incentives and national misconduct policies might affect scientific integrity. No clear support was found for the “pressures to publish” hypothesis. Female authors were found to be equally likely to publish duplicated images compared to males. Country-level parameters generally exhibited stronger effects than individual-level parameters, because developing countries were significantly more likely to produce problematic image duplications. This suggests that promoting good research practices in all countries should be a priority for the international research integrity agenda. (shrink)

There has been relatively little empirical research into the causes of research misconduct. To begin to address this void, the authors collected data from closed case files of the Office of Research Integrity (ORI). These data were in the form of statements extracted from ORI file documents including transcripts, investigative reports, witness statements, and correspondence. Researchers assigned these statements to 44 different concepts. These concepts were then analyzed using multidimensional scaling and cluster analysis. The authors chose a solution (...) consisting of seven clusters: (1) personal and professional stressors, (2) organizational climate, (3) job insecurities, (4) rationalizations A, (5) personal inhibitions, (6) rationalizations B and, (7) personality factors. The authors discuss the implications of their findings for policy and for future research. (shrink)

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

Despite organizational ethical training programs, some employees still engage in unethical behavior. As such, organizational researchers have sought to examine why employees engage in unethical behavior and whether interventions can improve ethical misconduct. While some instruments measure moral development or ethical/unethical behaviors toward the organization, this study utilized a unique scale which evaluates perceptions of ethical misconduct (PEMS). Data from a large Midwestern university, a large Southeastern university, and Amazon’s Mechanical Turk were used in the analyses. An exploratory and (...) confirmatory factor analyses were used in the creation of the PEMS. To examine the validity of the scale, the PEMS was correlated to scales which measure Dark Triad traits and Counterproductive Work Behaviors (CWBs). Findings showed a significant positive correlation between the PEMS and both scales. The results also show that the PEMS mediates the relationship between psychopathy and CWBs. (shrink)

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

The ethics of conducting research in epidemic situations have yet to account fully for differences in the proportion and acuteness of epidemics, among other factors. While epidemics most often arise from infectious diseases, not all infectious diseases are of epidemic proportions, and not all epidemics occur acutely. These and other variations constrain the generalization of ethical decision‐making and impose ethical demands on the individual researcher in a way not previously highlighted. This paper discusses a number of such constraints and impositions. (...) It applies the ethical principles enunciated by Emmanuel et al.1 to the controversial Pfizer study in Nigeria in order to highlight the particular ethical concerns of acute epidemic research, and suggest ways of meeting such challenges.The paper recommends that research during epidemics should be partly evaluated on its own merits in order to determine its ethical appropriateness to the specific situation. Snap decisions to conduct research during acute epidemics should be resisted. Community engagement, public notification and good information management are needed to promote the ethics of conducting research during acute epidemics. Individual consent is most at risk of being compromised, and every effort should be made to ensure that it is maintained and valid. Use of data safety management boards should be routine. Acute epidemics also present opportunities to enhance the social value of research and maximize its benefits to communities.Ethical research is possible in acute epidemics, if the potential challenges are thought of ahead of time and appropriate precautions taken. (shrink)

A sample survey of members of the Association of Environmental and Resource Economists (AERE) found relatively low rates of obvious ethical misconduct, such as data fabrication and falsification, and higher rates of dubious behaviors, such as deliberate overstatement of positive and understatement of negative results. AERE members reported that job-related pressures-including competition with peers, pressure due to professional implication and on-the-job pressure-were the most important causes. The most effective preventive measures, according to respondents, were discussion of ethics in existing (...) classes, codes of ethics, and short courses at professional meetings. The vast majority of AERE members were against government audits and regulations. (shrink)

The ethics of conducting research in epidemic situations have yet to account fully for differences in the proportion and acuteness of epidemics, among other factors. While epidemics most often arise from infectious diseases, not all infectious diseases are of epidemic proportions, and not all epidemics occur acutely. These and other variations constrain the generalization of ethical decision-making and impose ethical demands on the individual researcher in a way not previously highlighted. This paper discusses a number of such constraints and impositions. (...) It applies the ethical principles enunciated by Emmanuel et al.1 to the controversial Pfizer study in Nigeria in order to highlight the particular ethical concerns of acute epidemic research, and suggest ways of meeting such challenges. The paper recommends that research during epidemics should be partly evaluated on its own merits in order to determine its ethical appropriateness to the specific situation. Snap decisions to conduct research during acute epidemics should be resisted. Community engagement, public notification and good information management are needed to promote the ethics of conducting research during acute epidemics. Individual consent is most at risk of being compromised, and every effort should be made to ensure that it is maintained and valid. Use of data safety management boards should be routine. Acute epidemics also present opportunities to enhance the social value of research and maximize its benefits to communities. Ethical research is possible in acute epidemics, if the potential challenges are thought of ahead of time and appropriate precautions taken. (shrink)

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

Surveys of almost 1,500 members of three professional societies that do risk analysis found that 3 in 10 respondents had observed a biased research design, 2 in 10 had observed plagiarism, and 1 in 10 observed data fabrication or falsification. Respondents with many years in risk analysis, business consultants, and industrial hygienists reported the greatest prevalence of misconduct. These respondents perceived poor science, economic implications of the research, and lack of training in ethics as causes of misconduct. (...) They supported the teaching of ethics but the vast majority did not support government auditing of their work. (shrink)

Recent studies from Western countries indicate significant levels of questionable research practices, but similar data from low and middle-income countries are limited. Our aims were to assess the prevalence of and attitudes regarding research misconduct among researchers in several universities in the Middle East and to identify factors that might account for our findings. We distributed an anonymous questionnaire to a convenience sample of investigators at several universities in Egypt, Lebanon, and Bahrain. Participants were asked to a) self-report their (...) extent of research misconducts, as well as their knowledge of colleagues engaging in similar research misconducts and b) provide their extent of agreement with certain attitudes about research misconduct. We used descriptive, bivariate, and multivariate logistic regression statistics to analyze the data. Data from 278 participants showed a high prevalence of misconduct, as 59.4% of our respondents self-reported to committing at least one misbehaviors and 74.5% reported having knowledge of any misbehaviors among any of their colleagues. The most common type of self-report misconduct was “circumventing research ethics regulations” followed by “fabrication and falsification”. A significant predictor of misconduct included a lack of “prior ethics training”. Scientific misconduct represents a significant issue in several universities in the Middle East. The demonstration that a lack of “prior ethics training” was a significant predictor of misconduct should lead to educational initiatives in research integrity. Further studies are needed to confirm whether our results can be generalized to other universities in the Middle East. (shrink)

Reports of research fraud have raised concerns about research integrity similar to concerns raised about financial accounting fraud. We propose a departure from self-regulation in that researchers adopt the financial accounting approach in establishing trust through an external validation process, in addition to the reporting entities and the regulatory agencies. The general conceptual framework for reviewing financial reports, utilizes external auditors who are certified and objective in using established standards to provide an opinion on the financial reports. These standards have (...) become both broader in scope and increasingly specific as to what information is reported and the methodologies to be employed. We believe that the financial reporting overhaul encompassed in the US Sarbanes–Oxley Act of 2002, which aims at preventing accounting fraud, can be applied to scientific research in 4 ways. First, Sarbanes–Oxley requires corporations to have a complete set of internal accounting controls. Research organizations should use appropriate sampling techniques and audit research projects for conformity with the initial research protocols. Second, corporations are required to have the chief financial officer certify the accuracy of their financial statements. In a similar way, each research organization should have their vice-president of research (or equivalent) certify the research integrity of their research activities. In contrast, the primary responsibility of the existing Research Integrity Officers is to handle allegations of research misconduct, an after-the-fact activity. Third, generally accepted auditing standards specify the appropriate procedures for external review of a corporation’s financial statements. For similar reasons, the research review process would also require corresponding external auditing standards. Finally, these new requirements would be implemented in stages, with the largest 14 research organizations that receive 25% of the total National Institutes of Health funding, adopting these research oversight enhancements first. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:FDA Releases Draft Guidance on Regulation of Genetically Engineered AnimalsJohn P. Gluck (bio) and Mark T. Holdsworth (bio)On 18 September 2008, the U.S. Food and Drug Administration (FDA) issued a draft set of guidelines for those involved in developing genetically engineered animals with heritable recombinant DNA (rDNA) constructs and is requesting comment from industry and the public about their content. The document does not impose new regulations but details (...) how existing laws and regulations apply to genetically engineered (GE) animals and offers advice to developers on how to negotiate the laws in the most efficient and productive manner. The draft guidance document is not legally enforceable at this juncture, but the guidelines are recommendations reflecting the FDA's "current thinking on a topic."The modification of GE animals being developed for commercialization, which are the focus of the document, fall into six categories: modifications intended to (1) enhance food quality—e.g., faster growing fish and meats with better nutritional profiles; (2) improve animal health via increased resistance to disease—e.g., mastitis in dairy cattle and Bovine Spongiform Encephalopathy (BSE); (3) create so-called "biopharm" animals capable of producing therapeutic products such as insulin, clotting factors, and tissues for human transplantation; (4) reduce the barriers to human animal interaction—e.g., hypoallergenic pets; (5) develop valid animal models of human disease—e.g., Parkinson's disease, Lesh-Nyhan's syndrome, and cancer; and (6) improve production of industrial or consumer products such as fiber. The timing of the guidelines coincides with the FDA's belief in an expected boon in the number of GE animals approaching the stage of commercialization.The FDA's involvement in the approval process emerges from the new animal drug provisions of the Federal Food Drug and Cosmetic Act and the definition of what constitutes a drug. The Act defines a new animal drug as "an article (other than food) intended to affect the structure or any function of the body of... animals." A rDNA construct intended to affect the structure or function of an animal meets the definition of a new animal drug, regardless of whether the resulting GE animals are intended for human food or the production of pharmaceuticals or any other substances. [End Page 393]Before proceeding to a review of the draft guidelines, it is important briefly to set the controversies around GE animals in historical and ethical context.The Ethical DebateFrom its inception, the intentional genetic modification or genetic engineering of molecules, plants, and animals by the techniques of gene splicing has consistently elicited strong responses from both the scientific community and the public. There are some data to suggest that although the concerns of scientists fall primarily into the category of possible biohazards, those of the public also reflect great concern about the intrinsic moral issues, such as whether there is something fundamentally wrong with this line of work, making it a form of forbidden knowledge (see, e.g., Gaskell 1997). When news of Paul Berg's attempts in 1970 to graft the primate tumor virus (SV 40) onto the intestinal tract bacteria Escherichia coli for the purpose of studying how normal cells may be transformed into cancerous cells was shared with colleagues, he was strongly encouraged to reflect on the potential public health risks if somehow the altered bacteria broke containment and entered the environment. Thanks to Berg's leadership, these concerns soon resulted in conferences held in Asilomar, California, and New Hampton, New Hampshire, where the ethical responsibilities of microbiologists involved in this research were discussed. These initial discussions resulted in what has come to be known as "The Moratorium Letter" (Shattuck 1996) published in the journal Science in 1974. This letter, signed by 11 leaders in the field, actually recommended restrictions on several types of experiments that were considered to be particularly risky and stated "that adherence to our major recommendations will entail postponement or possibly abandonment of certain types of scientifically worthwhile experiments" (Berg 1974). An international conference on the issues came to similar conclusions about the need for a research moratorium for the sake of public safety. Recommendations arising from conference participants led to the formation of the National Institutes... (shrink)

Background: Use of patients’ medical data for secondary purposes such as health research, audit, and service planning is well established in the UK. However, the governance environment, as well as public understanding about this work, have lagged behind. We aimed to systematically review the literature on UK and Irish public views of patient data used in research, critically analysing such views though an established biomedical ethics framework, to draw out potential strategies for future good practice guidance and inform (...) ethical and privacy debates. Methods: We searched three databases using terms such as patient, public, opinion, and electronic health records. Empirical studies were eligible for inclusion if they surveyed healthcare users, patients or the public in UK and Ireland and examined attitudes, opinions or beliefs about the use of patient data for medical research. Results were synthesised into broad themes using a framework analysis. Results: Out of 13,492 papers and reports screened, 20 papers or reports were eligible. While there was a widespread willingness to share patient data for research for the common good, this very rarely led to unqualified support. The public expressed two generalised concerns about the potential risks to their privacy. The first of these concerns related to a party’s competence in keeping data secure, while the second was associated with the motivation a party might have to use the data. Conclusions: The public evaluates trustworthiness of research organisations by assessing their competence in data-handling and motivation for accessing the data. Public attitudes around data-sharing exemplified several principles which are also widely accepted in biomedical ethics. This provides a framework for understanding public attitudes, which should be considered in the development in any guidance for regulators and data custodians. We propose four salient questions which decision makers should address when evaluating proposals for the secondary use of data. (shrink)

Publications by Chinese researchers in scientific journals have dramatically increased over the past decade; however, academic misconduct also becomes more prevalent in the country. The aim of this prospective study was to understand the perceptions of Chinese biomedical researchers towards academic misconduct and the trend from 2010 to 2015. A questionnaire comprising 10 questions was designed and then validated by ten biomedical researchers in China. In the years 2010 and 2015, respectively, the questionnaire was sent as a survey to biomedical (...) researchers at teaching hospitals, universities, and medical institutes in mainland China. Data were analyzed by the Chi squared test, one-way analysis of variance with the Tukey post hoc test, or Spearman’s rank correlation method, where appropriate. The overall response rates in 2010 and 2015 were 4.5% and 5.5%, respectively. Data from 15 participants in 2010 were invalid, and analysis was thus performed for 1263 participants. Among the participants, 54.7% thought that academic misconduct was serious-to-extremely serious, and 71.2% believed that the Chinese authorities paid no or little attention to the academic misconduct. Moreover, 70.2 and 65.2% of participants considered that the punishment for academic misconduct at the authority and institution levels, respectively, was not appropriate or severe enough. Inappropriate authorship and plagiarism were the most common forms of academic misconduct. The most important factor underlying academic misconduct was the academic assessment system, as judged by 50.7% of the participants. Participants estimated that 40.1% of published scientific articles were associated with some form of academic misconduct. Their perceptions towards academic misconduct had not significantly changed over the 5 years. Reform of the academic assessment system should be the fundamental approach to tackling this problem in China. (shrink)

The online version of the original article can be found under doi:10.1007/s11948-007-9045-2.

BackgroundIncreasingly, hospitals and research institutes are developing technical solutions for sharing patient data in a privacy preserving manner. Two of these technical solutions are homomorphic encryption and distributed ledger technology. Homomorphic encryption allows computations to be performed on data without this data ever being decrypted. Therefore, homomorphic encryption represents a potential solution for conducting feasibility studies on cohorts of sensitive patient data stored in distributed locations. Distributed ledger technology provides a permanent record on all transfers and (...) processing of patient data, allowing data custodians to audit access. A significant portion of the current literature has examined how these technologies might comply with data protection and research ethics frameworks. In the Swiss context, these instruments include the Federal Act on Data Protection and the Human Research Act. There are also institutional frameworks that govern the processing of health related and genetic data at different universities and hospitals. Given Switzerland’s geographical proximity to European Union (EU) member states, the General Data Protection Regulation (GDPR) may impose additional obligations.MethodsTo conduct this assessment, we carried out a series of qualitative interviews with key stakeholders at Swiss hospitals and research institutions. These included legal and clinical data management staff, as well as clinical and research ethics experts. These interviews were carried out with two series of vignettes that focused on data discovery using homomorphic encryption and data erasure from a distributed ledger platform.ResultsFor our first set of vignettes, interviewees were prepared to allow data discovery requests if patients had provided general consent or ethics committee approval, depending on the types of data made available. Our interviewees highlighted the importance of protecting against the risk of reidentification given different types of data. For our second set, there was disagreement amongst interviewees on whether they would delete patient data locally, or delete data linked to a ledger with cryptographic hashes. Our interviewees were also willing to delete data locally or on the ledger, subject to local legislation.ConclusionOur findings can help guide the deployment of these technologies, as well as determine ethics and legal requirements for such technologies. (shrink)

This paper examines the consequences of a culture of “personal ethics” when using new methodologies, such as the use of social media sites as a source of data for research. Using SM research as an example, this paper explores the practices of a number of actors and researchers within the “Ethics Ecosystem” which as a network governs ethically responsible research behaviour. In the case of SM research, the ethical use of this data is currently in dispute, as even (...) though it is seemingly publically available, concerns relating to privacy, vulnerability, potential harm and consent blur the lines of responsible ethical research behaviour. The findings point to the dominance of a personal, bottom-up, researcher-led, ‘ethical barometer’ for making decisions regarding the permissibility of using SM data. We show that the use of different barometers by different researchers can lead to wide disparities in ethical practice - disparities which are compounded by the lack of firm guidelines for responsible practice of SM research. This has widespread consequences on the development of shared norms and understandings at all levels, and by all actors within the Ethics Ecosystem, and risks inconsistencies in their approaches to ethical decision-making. This paper argues that this governance of ethical behaviour by individual researchers perpetuates a negative cycle of academic practice that is dependent on subjective judgements by researchers themselves, rather than governed by more formalised academic institutions such as the research ethics committee and funding council guidelines. (shrink)

By examining managers’ decisions about disclosing updated assessments of firms’ risks, we present evidence that the risk factor disclosures are informative. We use the setting of cybersecurity risk factor disclosures after a data breach because data breaches, especially severe breaches, serve as a natural experiment where an exogenous shock to managers’ assessment of their firm’s cybersecurity risks occurs. We analyze the topic from the perspective of two different theoretical lenses: the economic lens of optimal (...) risk exposure and the ethical lens of stakeholder theory. Using a sample of firms experiencing data breaches, we find that firms experiencing a data breach increase the amount of cybersecurity risk factor disclosures compared to matched firms with no data breach. Further investigation reveals that the severity of data breaches affects the results; cybersecurity risk factor disclosures increase only after severe data breaches. While there is no significant market reaction if breached firms’ subsequent annual reports include increased cybersecurity risk factor disclosures, a significant negative market reaction occurs if breached firms decrease cybersecurity risk factor disclosures, regardless of the severity of the breach, implying that the market anticipates increased disclosures after data breaches. (shrink)

BackgroundPrevious studies have indicated that failure to report ethical approval is common in health science articles. In social sciences, the occurrence is unknown. The Swedish Ethics Review Act requests that sensitive personal data, in accordance with the EU General Data Protection Regulation (GDPR), should undergo independent ethical review, irrespective of academic discipline. We have explored the adherence to this regulation. MethodsUsing the Web of Science databases, we reviewed 600 consecutive articles from three domains (health sciences with and without (...) somatic focus and social sciences) based on identifiable personal data published in 2020. ResultsInformation on ethical review was lacking in 12 of 200 health science articles with somatic focus (6%), 21 of 200 health science articles with non-somatic focus (11%), and in 54 of 200 social science articles (27%; p < 0.001 vs. both groups of health science articles). Failure to report on ethical approval was more common in (a) observational than in interventional studies (p < 0.01), (b) articles with only 1–2 authors (p < 0.001) and (c) health science articles from universities without a medical school (p < 0.001). There was no significant association between journal impact factor and failure to report ethical approval.ConclusionsWe conclude that reporting of research ethics approval is reasonably good, but not strict, in health science articles. Failure to report ethical approval is about three times more frequent in social sciences compared to health sciences. Improved adherence seems needed particularly in observational studies, in articles with few authors and in social science research. (shrink)

This article proposes to identify risk factors for moral distress from the literature, validate them through expert analysis and provide the basis for a new tool to assess the risk of moral distress among nurses. Moral distress is related to the psychological, emotional and physiological aspects of nursing. It arises from constraints caused by various circumstances and can lead to significant negative consequences. A scoping review and validation through expert analysis were used. The research question guiding this study (...) was as follows: What is known about risk factors for moral distress in nursing? The research was conducted using multiple sources including electronic databases and lists of references from relevant literature. The final sample consisted of 38 studies. A validation analysis was conducted by experts during December 2014 and June 2015. To exclude a risk factor item, at least 80% of the experts had to agree with the exclusion. In total, 53 risk factors for moral distress were identified, reviewed by the experts and grouped to form a new instrument that may help to identify risk for moral distress and to address its consequences. (shrink)

We extend research on the effects of local audit office characteristics on audit quality by investigating whether audit offices in highly religious U.S. Metropolitan Statistical Areas exhibit going concern decisions that reflect heightened professional skepticism relative to audit offices in less religious MSAs. Prior research links religiosity to risk aversion and ethical development and suggests audit practice offices in more religious MSAs are more likely to issue going concern opinions because they will assess the effects of mitigating factors in (...) a more skeptical manner. Our results indicate that audit practice offices located in highly religious MSAs are more likely to issue going concern audit opinions, consistent with a more skeptical assessment of mitigating factors. Additional tests provide direct evidence consistent with the argument that these audit offices are more risk averse in issuing going concern opinions. Our findings are relevant to auditors, audit clients, researchers, and regulators. (shrink)

Among the many forms of research misconduct, publishing fraudulent data is considered to be serious where the confidence and validity of the research is detrimentally undermined. In this study, the trend of 303 retracted publications from 44 authors (with more than three retracted publications each) was analysed. The results showed that only 6.60% of the retracted publications were single-authored and the discovery of fraudulent publications had reduced from 52.24 months (those published before the year 2000) to 33.23 months (those (...) published on the year 2000 and onwards). It appears that with the widely accessible public databases like PubMed, fraudulent publications can be detected more easily. The different approaches adopted by authors who had previous publications retracted are also discussed herein. (shrink)

This exploratory study investigates the manifold conceptions of the internal auditing of risk culture prevalent among four influential actors of the financial sector—regulators, normalizers, consultants, and implementers. By inductive analysis of 20 interviews and 295 documents, we illustrate a two-step interpretive scheme utilized by the four actors in their IA approaches of risk culture: defining broad goals and designing visibility schemes. The visibility schemes were tied to the demarcation, measurement, as well as the IA data collection techniques (...) of risk culture. Our results indicate two dichotomous interpretations among the four actors concerning the IA of risk culture. The first interpretation, prevalent among regulators and implementers, promotes the control of risk culture primarily through verification. The second interpretation, adopted by consultants and normalizers, promotes the control of risk culture by IA along with the empowerment of employees through training programs. Our results not only contribute to understanding IA expansions, specifically to non-tangible domains such as risk culture but also enrich the literature exploring the mechanisms different stakeholders utilize to shape weakly professionalized IA practices. (shrink)

Researchers sometimes engage in various forms of dishonesty and unethical behavior, which has led to regulatory efforts to ensure that they work according to acceptable standards. Such regulation is a difficult task, as research is a diverse and dynamic endeavor. Researchers can disagree about what counts as good and acceptable standards, and these standards are constantly developing. This paper presents and discusses recent changes in research integrity and ethics regulation in Norway, Denmark, and Sweden. Recognizing that research norms are developed (...) through practice and are therefore unsuited for comprehensive national regulation, the Scandinavian countries focus on empowering the research community to regulate itself instead, except for the most severe cases of misconduct. This empowerment takes the form of giving research institutions tools and investigatory powers while also holding them responsible for ensuring that both the institution and individual researchers are up to date on relevant norms. In this way, the Scandinavian governments seek to avoid some of the challenges found in more legalistic approaches, which risk lagging behind the continuous development of research norms and can be insensitive to the fact that different disciplines have different norms. While the new approach in Scandinavian has several potential benefits, it also involves potential trade-offs and limitations. The new laws can create confusion about what researchers are allowed to do. Another issue is that it only addresses the fundamental drivers of misconduct to a limited extent. (shrink)

BackgroundPlagiarism is considered as serious research misconduct, together with data fabrication and falsification. However, little is known about biomedical researchers’ views on plagiarism. Moreover, it has been argued – based on limited empirical evidence – that perceptions of plagiarism depend on cultural and other determinants. The authors explored, by means of an online survey among 46 reputable universities in Europe and China, how plagiarism is perceived by biomedical researchers in both regions.MethodsWe collected work e-mail addresses of biomedical researchers identified (...) through the websites of 13 reputable universities in Europe and 33 reputable universities in China and invited them to participate in an online anonymous survey. Our questionnaire was designed to assess respondents’ views about plagiarism by asking whether they considered specific practices as plagiarism. We analyzed if respondents in China and Europe responded differently, using logistic regression analysis with adjustments for demographic and other relevant factors.ResultsThe authors obtained valid responses from 204 researchers based in China (response rate 2.1%) and 826 researchers based in Europe (response rate 5.6%). Copying text from someone else’s publication without crediting the source, using idea(s) from someone else’s publication without crediting the source and republishing one’s own work in another language without crediting the source were considered as plagiarism by 98, 67 and 64%, respectively. About one-third of the respondents reported to have been unsure whether they had been plagiarizing.Overall, the pattern of responses was similar among respondents based in Europe and China. Nevertheless, for some items significant differences did occur in disadvantage of Chinese respondents.ConclusionsFindings indicate that nearly all biomedical researchers understand (and disapprove of) the most obvious forms of plagiarism, but uncertainties and doubts were apparent for many aspects. And the minority of researchers who did not recognize some types of plagiarism as plagiarism was larger among China-based respondents than among Europe-based respondents. The authors conclude that biomedical researchers need clearer working definitions of plagiarism in order to deal with grey zones. (shrink)

We extend research on the effects of local audit office characteristics on audit quality by investigating whether audit offices in highly religious U.S. Metropolitan Statistical Areas exhibit going concern decisions that reflect heightened professional skepticism relative to audit offices in less religious MSAs. Prior research links religiosity to risk aversion and ethical development and suggests audit practice offices in more religious MSAs are more likely to issue going concern opinions because they will assess the effects of mitigating factors in (...) a more skeptical manner. Our results indicate that audit practice offices located in highly religious MSAs are more likely to issue going concern audit opinions, consistent with a more skeptical assessment of mitigating factors. Additional tests provide direct evidence consistent with the argument that these audit offices are more risk averse in issuing going concern opinions. Our findings are relevant to auditors, audit clients, researchers, and regulators. (shrink)

BackgroundThe risk of child sexual abuse among non-forensic, non-correctional patients with Pedophilic Disorder is largely unknown.MethodsWe recruited a consecutive sample of 55 help-seeking, non-correctional adult men diagnosed with DSM-5 PD at a university-affiliated sexual medicine outpatient unit in Sweden. PD participants were compared with 57 age-matched, non-clinical control men on four literature-based dynamic risk domains and self-rated child sexual abuse risk.ResultsPD participants scored higher than controls on all tested domains ; expectedly so for pedophilic attraction : [1.91–2.89]), (...) but also for sexual preoccupation, impaired self-regulation, impaired cognitive empathy and antisocial traits, and self-rated child sexual abuse risk. When summarizing all five domains into a pre-specified composite score, PD subjects scored substantially higher than matched control men. Five PD participants self-reported any previous conviction for a contact child sexual offense and eight for possession of child sexual abuse material or non-contact sexual offending. Eighteen subjects acknowledged past week, child-related sexual behaviors.ConclusionSelf-referred, help-seeking men with PD scored higher than non-clinical control men on psychiatric measures of dynamic risk of child sexual abuse suggested in prior research with correctional samples diagnosed with PD. Our findings, including the composite risk measure, might inform clinical practice, but needs validation against actual sexual offending behavior. (shrink)

The relationship between stress and unethical behaviour amongst non-tenured research staff in academia is a relatively unexplored phenomenon. The research reported herein was therefore carried out with the aim of exploring the relationship between stress, the socio-organisational factors which contribute to it, job satisfaction, perceptions of job instability, and the occurrence of unethical behaviour in research. 793 Italian researchers participated in the research—all of whom were working on fixed-term contracts—after being individually requested to complete an online questionnaire. The data (...) indicate that unethical behaviours occur with alarming frequency. The stress level reported is quite high, as is the level of perceived job insecurity, both of which impact upon levels of job satisfaction. Perceived stress levels also seem to play a role in the commission of unethical behaviours, but this relationship is irrelevant when one considers the role of social and organisational factors that are known to induce it. Indeed, it seems that there are various socio-organisational determinants of stress that have an obvious direct negative influence on the commission of unethical behaviours more than the stress level per se. This research paints a worrying picture in relation to the psycho-physical state of non-tenured researchers as a result of the working conditions in which they find themselves in Italian universities. (shrink)

This study aims to determine the opinions of teachers of Religious Culture and Ethics Course (DKAB) about subject-based classroom application in-depth. The research has been carried from qualitative research methods with a case study design. In order to determine the working group of the study, criteria sampling was used in the first stage, and the maximum diversity sampling method was used in the next step. The sample of this research consists of 8 DKAB teachers working in Ankara province. A semi-structured (...) interview form has been used as a data collection tool in the study. The data of the qualitative of this research has been analyzed with both descriptive and content analysis by NVivo 10 program. In order to ensure validity and reliability in the study, credibility, transferability, consistency, and verifiability strategies have been used. When the research data were analyzed, four themes were formed: positive opinions about the application, negative opinions and problems related to the application, contribution of the practice to religious education and training, and recommendations about the application. DKAB teachers find the application more positive than the classroom system. It has been found that the practice of subject-based classrooms is a motivational tool for Primary School students, while it causes some problems for lower secondary school and upper secondary school students.Summary: Learning environments are among the key elements in the acquisition of 21st-century skills. Classrooms are also a part of the learning environment. Classes are the learning environment in which teachers and students spend most of their education and training process. In this context, subject-based classroom application is one of the preferred methods in the arrangement of classrooms.Subject-based classroom application means that the teachers have a special classroom related to their branches in the school building, and students attend the teacher's classroom according to the syllabus. In this practice, the teacher can decorate walls, floor, ceiling, column, and beam of the classroom with students’ study materials such as banner, poster, painting, cartoon to make the course more effective and efficient and to create a psychological atmosphere called classroom atmosphere-air.This application aims to activate the student by enriching the classroom and make learning effective and efficient. The classroom equipped with appropriate equipment and materials provides a favorable environment for the implementation of effective teaching strategies. The application can create “class/classroom culture” by using ordinary meanings and symbols related to the course. It provides students the opportunity to exhibit their products and contributes to students' self-regulation skills development. Besides, real-life practices or practices close to reality can be brought into the classroom. As a result, permanent learning can be realized with the possibility of creating a shared living space and the number of sensory organs participating in learning.This current study aims to address in-depth information about the opinions of Religious Culture and Moral Ethics (DKAB) teachers in primary, secondary, and high schools regarding the subject-based classroom application. When the studies in the literature are examined, it is seen that the studies related to the subject-based classroom application have increased since 2010. However, it is clear that this research is directed towards social studies, geography, science, and mathematics courses and is based on the opinions of students, teachers, and administrators at the secondary school level. In the context of DKAB course, there has been no research including the views of teachers, students, or school administrators regarding the application of subject-based classrooms. This study is carried out revealing perspectives of DKAB teachers by examining their opinions on the subject-based classroom application and contribute to the field. The research was conducted with a case study design from the qualitative research methods. The participants consist of 8 DKAB teachers working in Ankara province. A mixed purposive sampling method was used to determine the study group. In the first stage, the teachers implementing the DKAB classrooms application were taken as criteria. In the next step, the study group was determined within the framework of the maximum diversity sampling method by considering the variables such as school level, gender, age, education level, duration of teachers' work. The data were collected through a semi-structured interview form with expert opinion. In the form, there are nine main questions and probe questions, which include questions related to subject-based classrooms application, the contribution of the application to religious education and training, the contribution of teachers to professional and personal development, the effect of teachers' belonging to the school, the effectiveness, and improvement of the application. Permission has been obtained from the Ankara Provincial Directorate of National Education and participants via consent form for the interview. The interviews were recorded in audio, 169.58-minute audio recording transcripts, and 52-page interview data obtained. The qualitative data of this research has been analyzed with both descriptive and content analysis by NVivo 10 program. In order to ensure validity and reliability in the study, credibility, transferability, consistency, and verifiability strategies have been used.When the data of the research were analyzed, the opinions of DKAB teachers about the subject-based classrooms application categorized under four themes; positive and negative opinions/problems about the practice, the contribution of the practice to religious education and teaching and practical suggestions. Under the theme of positive opinions on the application, positive aspects for the teacher, student, parents, and comparison with the classroom system were formed. According to the participants, the practice of DKAB classroom is a “facilitation” element for the teacher because of the factors such as the teacher not moving around the classroom, not carrying material, having freedom to organize the classroom, and material regularity. In this application, since the teacher has a class of his own, the teacher adopts and owns the classroom and the sense of belonging to school increases. This sense of belonging is felt so strongly that there is even a participant who plans to retire if the application is abandoned. The positive aspects of the application for the students are that; a classroom is a motivating tool, the boards and walls can be used, and the student has the opportunity to exhibit their activities. When compared with the classroom system, it was stated that as a result of the branch classroom practice, the school equipment could be better protected, class order and cleaning easier, and the success of the students would be increased.The negative views of the participants on the application were grouped under the categories of students, teachers, and parents. Not having a fixed class of their own, continually relocating and losing time in recess, staying in the classroom door when the classroom is locked, not adopting the classroom and lack of lockers constitute the negative aspects of the application for the students. The overuse of classrooms, less use of teachers' rooms, lack of communication between colleagues are the negative aspects of the application for the teachers. It was stated by (75%) most of the participants that branch classroom application contributed to the continual learning of students in religious education and teaching. To make the application more functional, DKAB teachers have proposed arrangements such as improving physical infrastructure, enriching teaching materials, and arranging school syllabus and keeping classrooms open. As a result, teachers find the application more positive than the classroom system. While it is a motivation tool for primary school students, it causes some problems for secondary and high school students, such as carrying bags, staying at the door, and wasting time. In this sense, the application is recommended to be applied in primary schools that have a sufficient number of classrooms. Also, the system should be applied in secondary and high schools where the number of students is low, or the number of classrooms is sufficiently provided that the problems experienced by the students are eliminated. School administrations and teachers need to take necessary measures to make the application effective and efficient. (shrink)

Nearly 90 % of allegations of biomedical research misconduct in the United States are dismissed by responsible institutions without any faculty assessment or auditable record. Recently, members of the U.S. Congress have complained that the penalties for those against whom findings of research misconduct are made are too light and that too few grant funds associated with research misconduct have been recovered for use by other researchers and taxpayers. Here we discuss the laws that empower federal agencies that can oversee (...) investigations of biomedical research misconduct: the Office of Research Integrity and the Office of the Inspector General, both located within the Department of Health and Human Services. Research misconduct investigations pertaining to U.S. physical sciences funded through the National Science Foundation are overseen by the NSF’s OIG. While OIGs may provide some improvement over the ORI in the handling of research misconduct, we have found that a much more serious flaw exists which undermines an ability to conduct performance audits of the effectiveness by which allegations of research misconduct are handled in the United States. Specifically, sufficient data do not need to be retained by U.S. research institutions funded by HHS or NSF to allow effective audit of why allegations of research misconduct are dismissed before being seen by faculty inquiry or investigative committees. U.S. federal Generally Accepted Government Auditing Standards, if applied to the research misconduct oversight process, would allow a determination of whether the handling of allegations of biomedical research misconduct actually functions adequately, and if not, how it might be improved. In particular, we propose that independent, external peer review under GAGAS audit standards should be instituted without delay in assessing the performance of ORI, or any other similarly tasked federal agency, in handling allegations of research misconduct. (shrink)

Few studies exist which look at psychological factors associated with physician sexual misconduct. In this study, we explore family dysfunction as a possible risk factor associated with physician sexual misconduct. Six hundred thirteen physicians referred to a continuing medical education (CME) course for sexual misconduct were administered the FACES-II survey, a validated and reliable measure of family dynamics. The survey was part of a self-learning activity. We collected data from February 2000 to February 2009. Participants were predominantly (...) white, middle-aged males who represented the full range of medical specialties. Their results were compared against a sample of 177 physicians. The FACES-II is a self-report test that measures family of origin (the family in which one was raised) dynamics on two dimensions (1) flexibility, ranging from too flexible (chaotic) to not flexible enough (rigid) and (2) cohesion ranging from too close (enmeshed) to not close enough (disengaged). The most common family pattern observed among physicians accused of sexual misconduct was rigid flexibility paired with disengaged cohesion, indicative of unhealthy family functioning. This pattern was significantly different than the pattern observed in the comparison group. Physicians who engage in sexual misconduct are more likely to have family of origin dysfunction. Ethics is developmental and learned in one’s family of origin. Family of origin dynamics may be one risk factor predisposing one to ethical violations. These findings have important implications for screening, education, and treatment across the medical education continuum. (shrink)

A new etiological model is proposed for schizophrenia that combines variability‐enhancing nonspecific factors acting during development with more specific risk factors. This model is better suited than the current etiological models of schizophrenia, based on the risk factors paradigm, for predicting and/or explaining several important findings about schizophrenia: high co‐morbidity rates, low specificity of many risk factors, and persistence in the population of the associated genetic polymorphisms. Compared with similar models, e.g., de‐canalization, common psychopathology factor, sexual‐selection, (...) or differential sensitivity to the environment, this proposal is more general and integrative. Recently developed research methods have proven the existence of genetic and environmental factors that enhance developmental variability. Applying such methods to newly collected or already available data can allow for testing the hypotheses upon which this model is built. If validated, this model may change the understanding of the etiology of schizophrenia, the research models, and preventionbrk paradigms. (shrink)

Many preventive intervention studies with adolescents address high-risk behaviors such as drug and alcohol use, and unprotected sex. Randomized controlled trials (RCT) are the gold standard methodology used to test the effectiveness of these behavioral interventions. Interventions outside the rigidly described protocol are prohibited. However, there are ethical challenges to implementing inflexible intervention protocols, especially when the target population is young, experiences many stressful events, and lives in a resource-poor environment. Teens who are at high risk for substance (...) use or sexual risk behaviors tend to be at risk for other problems such as exposure to violence, sexual and physical abuse, depression, and homelessness. How should investigators deal with the psychological and social needs of teenagers in prevention programs in an ethically appropriate way and at the same time preserve the validity of RCT results? We have identified program characteristics, participant characteristics, interaction with parents, and problems with adolescents not in the study as sources of ethical dilemmas in RCT with at-risk adolescents. As a result of our experience, we recommend that every behavioral intervention study develop an ethics protocol, which should include rules for providing help to participants, has contact information for experts to provide guidance, and an emergency procedure for dealing with life threatening situations. In addition, studies should have a resource manual, train research staff in these ethical issues, and work with a data safety and monitoring board or ethics committee. (shrink)

The capacity to collect and analyse data is growing exponentially. Referred to as ‘Big Data’, this scientific, social and technological trend has helped create destabilising amounts of information, which can challenge accepted social and ethical norms. Big Data remains a fuzzy idea, emerging across social, scientific, and business contexts sometimes seemingly related only by the gigantic size of the datasets being considered. As is often the case with the cutting edge of scientific and technological progress, understanding of (...) the ethical implications of Big Data lags behind. In order to bridge such a gap, this article systematically and comprehensively analyses academic literature concerning the ethical implications of Big Data, providing a watershed for future ethical investigations and regulations. Particular attention is paid to biomedical Big Data due to the inherent sensitivity of medical information. By means of a meta-analysis of the literature, a thematic narrative is provided to guide ethicists, data scientists, regulators and other stakeholders through what is already known or hypothesised about the ethical risks of this emerging and innovative phenomenon. Five key areas of concern are identified: informed consent, privacy, ownership, epistemology and objectivity, and ‘Big Data Divides’ created between those who have or lack the necessary resources to analyse increasingly large datasets. Critical gaps in the treatment of these themes are identified with suggestions for future research. Six additional areas of concern are then suggested which, although related have not yet attracted extensive debate in the existing literature. It is argued that they will require much closer scrutiny in the immediate future: the dangers of ignoring group-level ethical harms; the importance of epistemology in assessing the ethics of Big Data; the changing nature of fiduciary relationships that become increasingly data saturated; the need to distinguish between ‘academic’ and ‘commercial’ Big Data practices in terms of potential harm to data subjects; future problems with ownership of intellectual property generated from analysis of aggregated datasets; and the difficulty of providing meaningful access rights to individual data subjects that lack necessary resources. Considered together, these eleven themes provide a thorough critical framework to guide ethical assessment and governance of emerging Big Data practices. (shrink)

The current study aims to construct and validate a measure of research misconduct for social science university students. The research is comprised of three studies; Study I presents the scale construction in three phases. In Phase I, the initial pool of items was generated by reviewing the literature and considering the results of semi-structured interviews. Phase II involved a psychometric cleaning of items, after which 38 items were retained. In Phase III, those 38 items were proposed to 652 university students, (...) and data were exposed to exploratory factor analysis, which extracted a one-factor structure with 15 items and 55.73% variance. Study II confirmed the factorial structure of the scale using an independent sample of university students. Confirmatory factor analysis of the scale demonstrates a good model fit to the data with the one-factor structure established through the exploratory factor analysis. The scale exhibits good internal consistency, with a Cronbach’s alpha of 0.95. Study III involves validation of the scale, with evidence for convergent validity collected from a sample of university students. The results reveal that the research misconduct scale has significant positive correlations with academic stress and procrastination and a significant negative correlation with academic achievement. The obtained convergent validity testifies that the scale can be considered a psychometrically sound instrument to measure research misconduct among social science university students. (shrink)

Although regulators have identified ethical lapses as a key factor contributing to auditors’ failure to detect their clients’ fraudulent financial reporting, research using ethical theory to examine auditors’ fraud detection remains limited. We provide evidence on the joint effect of ethical idealism and trait skepticism on auditors’ fraud judgments. Ethical idealism reflects an individual’s concern for the welfare of others while trait skepticism reflects an individual’s disposition to validating a proposition. Forsyth theorizes that there is an association between ethical (...) idealism and tolerance for deception. Drawing on that insight, we posit that ethical idealism and trait skepticism have a complementary effect on auditors’ fraud planning performance. This is because the former determines an auditor’s tolerance for allowing a client to get away with an ethically questionable act while the latter is important in determining how evidence is generally sought and evaluated. We used the Forsyth ethical position questionnaire to measure ethical idealism and the Hurtt :149–171, 2010) scale to measure trait skepticism. Our results indicate that there is a significant positive association between trait skepticism and the number of effective audit procedures but only for auditors who have high ethical idealism. The results highlight the importance of measuring and controlling for the effects of these traits when evaluating fraud detection performance. The paper also contributes by showing that an ethics theory can generate additional understanding of and insights into an important accounting phenomenon. (shrink)

BackgroundThe proper and ethical inclusion of PWLHIV and their young children in research is paramount to ensure valid evidence is generated to optimize treatment and care. Little empirical data exists to inform ethical considerations deemed most critical to these populations. Our study aimed to systematically review the empiric literature regarding ethical considerations for research participation of PWLHIV and their young children.MethodsWe conducted this systematic review in partnership with a medical librarian. A search strategy was designed and performed within the (...) following electronic databases: Ovid MEDLINE, Embase and CINAHL. We screened titles and abstracts using the following inclusion criteria: (1) a study population of PWLHIV or children under 5 years of age; and (2) collection of qualitative or quantitative data regarding ethics of research participation. Excluded were reviews, commentaries, policy statements, clinical care-related ethics concerns, abstracts, case studies, or studies unrelated to HIV research. Studies were appraised for quality, data were extracted, and studies were qualitatively analyzed using a principle-based ethical framework within the Belmont Report.ResultsOf the 7470 titles identified, 538 full-text articles were reviewed for eligibility and only three articles met full criteria for inclusion within this review. While we allowed for inclusion of studies involving young children born to mothers with HIV, only articles focused on PWLHIV were identified. Within the results of these studies, four themes emerged: (1) adequacy of informed consent; (2) consideration of paternal involvement; (3) balancing risks; and (4) access to research and treatment. A strength of this review is that it included perspectives of international research investigators, community leaders, and male partners. However, only two studies collected empiric data from PWLHIV regarding their experiences participating in researchConclusionResearchers and funding agencies should be aware of these considerations and appreciate the value of and critical need for formative research to ensure clinical trials involving PWLHIV promote ethical, well-informed research participation and, ultimately, improve care outcomes. More research is needed to create a comprehensive ethical framework for researchers when conducting studies with PWLHIV. (shrink)

Background: Nurses, social workers, and medical residents are ethically mandated to engage in policy advocacy to promote the health and well-being of patients and increase access to care. Yet, no instrument exists to measure their level of engagement in policy advocacy. Research objective: To describe the development and validation of the Policy Advocacy Engagement Scale, designed to measure frontline healthcare professionals’ engagement in policy advocacy with respect to a broad range of issues, including patients’ ethical rights, quality of care, culturally (...) competent care, preventive care, affordability/accessibility of care, mental healthcare, and community-based care. Research design: Cross-sectional data were gathered to estimate the content and construct validity, internal consistency, and test–retest reliability of the Policy Advocacy Engagement Scale. Participants and context: In all, 97 nurses, 94 social workers, and 104 medical residents were recruited from eight acute-care hospitals in Los Angeles County. Ethical considerations: Informed consent was obtained via Qualtrics and covered purposes, risks and benefits; voluntary participation; confidentiality; and compensation. Institutional Review Board approval was obtained from the University of Southern California and all hospitals. Findings: Results supported the validity of the concept and the instrument. In confirmatory factor analysis, seven items loaded onto one component with indices indicating adequate model fit. A Pearson correlation coefficient of.36 supported the scale’s test–retest stability. Cronbach’s α of.93 indicated strong internal consistency. Discussion: The Policy Advocacy Engagement Scale demonstrated satisfactory psychometric properties in this initial test. Findings should be considered within the context of the study’s limitations, which include a low response rate and limited geographic scope. Conclusion: The Policy Advocacy Engagement Scale appears to be the first validated scale to measure frontline healthcare professionals’ engagement in policy advocacy. With it, researchers can analyze variations in professionals’ levels of policy advocacy engagement, understand what factors are associated with it, and remedy barriers that might exist to their provision of it. (shrink)

This paper contends that a research ethics approach to the regulation of health data research is unhelpful in the era of population‐level research and big data because it results in a primary focus on consent (meta‐, broad, dynamic and/or specific consent). Two recent guidelines – the 2016 WMA Declaration of Taipei on ethical considerations regarding health databases and biobanks and the revised CIOMS International ethical guidelines for health‐related research involving humans – both focus on the growing reliance on (...) health data for research. But as research ethics documents, they remain (to varying degrees) focused on consent and individual control of data use. Many current and future uses of health data make individual consent impractical, if not impossible. Many of the risks of secondary data use apply to communities and stakeholders rather than individual data subjects. Shifting from a research ethics perspective to a public health lens brings a different set of issues into view: how are the benefits and burdens of data use distributed, how can data research empower communities, who has legitimate decision‐making capacity? I propose that a public health ethics framework – based on public benefit, proportionality, equity, trust and accountability – provides more appropriate tools for assessing the ethical uses of health data. The main advantage of a public health approach for data research is that it is more likely to foster debate about power, justice and equity and to highlight the complexity of deciding when data use is in the public interest. (shrink)

Accounting firms are reporting the use of Artificial Intelligence in their auditing and advisory functions, citing benefits such as time savings, faster data analysis, increased levels of accuracy, more in-depth insight into business processes, and enhanced client service. AI, an emerging technology that aims to mimic the cognitive skills and judgment of humans, promises competitive advantages to the adopter. As a result, all the Big 4 firms are reporting its use and their plans to continue with this innovation in (...) areas such as audit planning risk assessments, tests of transactions, analytics, and the preparation of audit work-papers, among other uses. As the uses and benefits of AI continue to emerge within the auditing profession, there is a gradual awakening to the fact that unintended consequences may also arise. Thus, we heed to the call of numerous researchers to not only explore the benefits of AI but also investigate the ethical implications of the use of this emerging technology. By combining two futuristic ethical frameworks, we forecast the ethical implications of the use of AI in auditing, given its inherent features, nature, and intended functions. We provide a conceptual analysis of the practical ethical and social issues surrounding AI, using past studies as well as our inferences based on the reported use of the technology by auditing firms. Beyond the exploration of these issues, we also discuss the responsibility for the policy and governance of emerging technology. (shrink)

The authors report the first Italian experience of a research ethics committee (REC) audit focused on the evaluation of the REC’s compliance with standard operating procedures, requirements in insurance coverage, informed consent, protection of privacy and confidentiality, predictable risks/harms, selection of subjects, withdrawal criteria and other issues, such as advertisement details and justification of placebo. The internal audit was conducted over a two-year period (March 2009–February 2011) divided into quarters to better value the influence of the new insurance coverage regulation (...) that came into effect in March 2010 (Ministerial Decree of 14 July, 2009) and expand the requirements to safeguard participants in clinical drug trials including other critical items as information and consent and the risks to benefits ratio. Out of a total of 639 REC’s opinions and research studies, 316 were reviewed. Regarding the insurance policy requirements, Auditor/REC non-compliance occurred only in one case. The highest number of Auditor/REC non-compliance was in regard to information and consent, which should have incurred a suspended decision rather than a favorable opinion. This internal audit shows the importance and the difficulty of the review process. For this reason, specific courses for members of the research ethics committee and for those who aspire to become auditors will be provided. There may also be efforts to improve the standard operating procedures already in place. (shrink)

Background Regulations on research ethics in France have evolved considerably over the past four years: the implementation of the Jardé law and of the General Data Protection Regulations have changed the landscape of research ethics for research involving or not involving human persons. In a context of creation of an Institutional Review Board at the University of Bordeaux, France, we sought to explore research ethics practices and perceptions in the medical community of our University Hospital. Methods A short questionnaire (...) was sent to all physicians of the University Hospital of Bordeaux. The questionnaire included closed questions and main topics were: physicians’ education in research ethics, ethics practices concerning researches non implying human persons, and physicians’ perceptions about current regulations. Results 86 questionnaires were sent back. If a majority of physicians have validated Good Clinical Practices trainings, there was a low rate of specific training on fundamental references in research ethics and a high proportion of responders do not consider themselves as educated in research ethics after completion of GCPs. Regulations on research ethics have many implications on medical research, especially by inducing changes in protocols in order to alleviate ethical requirements. Malpractices were acknowledged like false mention of positive opinion from an ethics committee. If If a majority of responders considers regulations as a positive answer to research ethics, a large majority considers it as a constraint and a complexification of research process. For 58%, regulations in research ethics are perceived as a hindrance for research initiatives. Conclusion Because of their impact on research process, regulations seem to constitute a scarecrow for physicians. Lack of training, bad representations and questionable practices highlight the need to improve education and to propose concrete guidance for medical researchers. (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 accelerating adoption of electronic health record systems will have profound impacts on clinical care. It will also have far-reaching implications for public health research and surveillance, which in turn could lead to changes in public policy, statutes, and regulations. The public health benefits of EHR use can be significant. However, researchers and analysts who rely on EHR data must proceed with caution and understand the potential limitations of EHRs.Much has been written about the risk of EHR privacy (...) breaches. This paper focuses on a different set of concerns, those relating to data quality. Unlike clinical trial data, EHR data is not recorded primarily to meet the needs of researchers. Because of clinicians’ workloads, poor user-interface design, and other factors, EHR data is surprisingly likely to be erroneous, miscoded, fragmented, and incomplete. Although EHRs eliminate the problem of cryptic handwriting, other kinds of errors are more common with EHRs than with paper records. (shrink)

Patient safety has only recently been subjected to wide-spread systematic study. Healthcare differs from other high risk industries in being more diverse and multi-contextual, and less certain and regulated. Also many patient safety problems are low-frequency events associated with many, varied contributing factors. The subject of this paper is the epistemology of patient safety (the science of the method of finding out about patient safety). Patient safety research is considered here on the background of a risk management framework (...) which requires researchers to: • Understand the context - as a subset of healthcare quality, services and systems research, with technical and human behavioural (cultural) components and a range of external and internal organisational influences, a wide range of research disciplines is necessary • Identify the risks - identify the things that go wrong and the frequency and nature of different types of incidents from sources such as medical record review, observational studies, audit, incident and medico-legal reports • Analyse the risks - deconstruct the things that go wrong, identifying contributing factors and trying to detect trends and patterns in contributing factors, detection, mitigation factors, ameliorating factors and actions taken to reduce risk • Evaluate the risks - decide on priorities, identifying preventive and corrective strategies and judging the risk- and cost-benefit of potential corrective strategies such as standardisation or simplification of a process or device • Manage the risk - evaluate and scope preventive and/or corrective strategies and then implement these, or place the problem on a risk register pending solution, or accept that what is needed is unaffordable • Communicate and consult - use interactive sessions, audit, on-going feedback, reminders and patient mediated prompts • Monitor and review the state of the problem - get baseline trends and patterns so that changes can be tracked and properly attributed to an intervention A hierarchy of levels of evidence has been proposed for clinical research and we argue that insufficient weighting has been given to lower ranked levels of research and to qualitative research, although critical interpretive synthesis is now gaining acceptance in mainstream thinking (e.g. by the Cochrane Collaboration). Fundamental challenges remain including how to grasp the elusive concept of patient safety, how to quantify, characterise and cost the problems, how to judge the extent to which harm can be attributed to errors, violations or system failures, how to identify contributing factors and the extent to which they can be implicated, how to judge whether incidents or their precursors are preventable, how to generate strong evidence to make healthcare safer and how to translate research into practice. Future directions include addressing the mundane as well as rare, dramatic events, and developing further research in non-hospital settings and in developing countries. In summary, a mixture of qualitative and quantitative methods, using information from all available data sources and combining retrospective, real time and prospective study designs, is necessary to address some of the more difficult patient safety problems. (shrink)

The prevalence and characteristics of research misconduct have mainly been studied in highly developed countries. In moderately or poorly developed countries such as Croatia, data on research misconduct are scarce. The primary aim of this study was to determine the rates at which scientists report committing or observing the most serious forms of research misconduct, such as falsification, fabrication, plagiarism, and violation of authorship rules in the Croatian scientific community. Additionally, we sought to determine the degree of development and (...) the extent of implementation of the system for defining and regulating research misconduct in a typical scientific community in Croatia. An anonymous questionnaire was distributed among 1232 Croatian scientists at the University of Rijeka in 2012/2013 and 237 returned the survey. Based on the respondents who admitted having committed research misconduct, 9 admitted to plagiarism, 22 to data falsification, 9 to data fabrication, and 60 respondents admitted to violation of authorship rules. Based on the respondents who admitted having observed research misconduct of fellow scientists, 72 observed plagiarism, 69 observed data falsification, 46 observed data fabrication, and 132 respondents admitted having observed violation of authorship rules. The results of our study indicate that the efficacy of the system for managing research misconduct in Croatia is poor. At the University of Rijeka there is no document dedicated exclusively to research integrity, describing the values that should be fostered by a scientist and clarifying the forms of research misconduct and what constitutes a questionable research practice. Scientists do not trust ethical bodies and the system for defining and regulating research misconduct; therefore the observed cases of research misconduct are rarely reported. Finally, Croatian scientists are not formally educated about responsible conduct of research at any level of their formal education. All mentioned indicate possible reasons for higher rates of research misconduct among Croatian scientists in comparison with scientists in highly developed countries. (shrink)

The European Union Data Protection Regulation will have profound implications for public health, health services research and statistics in Europe. The EU Commission's Proposal was a breakthrough in balancing privacy rights and rights to health and healthcare. The European Parliament, however, has proposed extensive amendments. This paper reviews the amendments proposed by the European Parliament Committee on Civil Liberties, Justice and Home Affairs and their implications for health research and statistics. The amendments eliminate most innovations brought by the Proposal. (...) Notably, derogation to the general prohibition of processing sensitive data shall be allowed for public interests such as the management of healthcare services, but not health research, monitoring, surveillance and governance. The processing of personal health data for historical, statistical or scientific purposes shall be allowed only with the consent of the data subject or if the processing serves an exceptionally high public interest, cannot be performed otherwise and is legally authorised. Research, be it academic, government, corporate or market research, falls under the same rule. The proposed amendments will make difficult or render impossible research and statistics involving the linkage and analysis of the wealth of data from clinical, administrative, insurance and survey sources, which have contributed to improving health outcomes and health systems performance and governance; and may illegitimise efforts that have been made in some European countries to enable privacy-respectful data use for research and statistical purposes. If the amendments stand as written, the right to privacy is likely to override the right to health and healthcare in Europe. (shrink)

The present study used quantitative and qualitative measures to examine Iranian applied linguists’ (mis-) conceptions of ethical issues in research. For this purpose, one hundred and twelve applied linguists completed a research ethics questionnaire constructed and validated by the researchers. In the follow-up qualitative phase, 15 applied linguists who were faculty members participated in semi-instructed interviews. Data were analyzed using exploratory factors analyses for the first phase and theme analyses for the second phase. Quantitative results showed that the most (...) important misconceptions among Iranian applied linguists lingered on working with data (data collection and data analyses). For example, removing an outlier was a prevalent act conducted by applied linguists in the present study. Teachers using their students as participants of their own research as well as how they treated those students after a study were other controversial issues. The qualitative results revealed several themes including _lack of knowledge, conflict with real-world practices, a product-oriented approach to education and a publish or perish mentality_ as the reasons for misconceptions of ethics in applied linguistics among Iranian researchers. On general terms, there was an implicit agreement regarding the lack of training on research ethics among Iranian applied linguists. (shrink)