9. KEY LEGISLATION AND OTHER REGULATIONS WITH WHICH RESEARCHERS SHOULD BE
9.11 Publication ethics and questions of misconduct
Some important documents on research ethics, such as the Declaration of Helsinki, address aspects of
publishing ethics. As the Swedish Research Council has signed the Berlin Declaration (the Berlin Declaration
on Open Access to Knowledge in the Sciences and Humanities), the Council has since 2010 included a requirement for open access publication in its calls for grant applications.
Two international documents are of particular relevance in this context: one being, the Editorial Policy Statements of the Council of Science Editors (CSE), and the other – and most important – the “Vancouver Rules”, published by the International Committee of Medical Journal Editors (ICMJE) under the title of Uniform Requirements for Manuscripts Submitted to Biomedical Journals. A point emphasised in both these documents is the clear link between the right to be credited as an author and the obligation to assume responsibility for and have contributed to the intellectual content of the publication.
Shared authorship is addressed in the CSE’s Recommendations for Group- Author Articles in Scientific Journals and Bibliometric Databases. Many journals today also refer to the ethical guidelines launched by the British Committee on Publication Ethics (COPE).
Constant departures from these standards have led other actors to intensify their work with publication ethics. Not least, publishing companies themselves have started formulating rules and guidelines. Groups of researchers, editors and funding bodies have also collaborated in drawing up a number of standards, such as CONSORT, STARD, STROBE and STREGA, for how various types of studies should be presented in journals. These and other documents can be found on the CODEX website’s page on publication ethics.
As regards research misconduct in general, perhaps the most important initiative in recent time is the OECD’s Best Practices for Ensuring Scientific Integrity and Preventing Misconduct, and another one produced by ALLEA, the European Code of Conduct for Research Integrity Revised Edition. The US federal guidelines, U.S. Federal Policy on Research Misconduct, have also received a great deal of attention. The European Science Foundation’s contribution is a discussion of Research Integrity in its Briefing no. 30. In Sweden, the Association of Swedish Higher Education has presented guidelines for the handling of questions of research misconduct by universities and higher education institutions in its Riktlinjer för hantering vid universitet och högskolor av frågor om vetenskaplig ohederlighet.
The most recent contribution to the documents on misconduct, the Singapore Statement on Research Integrity, was drawn up at the 2nd World Conference on Research Integrity.
References
1. 2nd World Conference on Research Integrity. Singapore Statement on Research Integrity. Singapore, 2010. Arkivförordning (SFS 1991:446).
2. Arkivlag (SFS 1990:782).
3. Berlin Declaration on Open Access to Knowledge in the Sciences and Humanities. Berlin, 2003.
4. Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. European Community, Brussels, 2005.
5. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, (Oviedo Convention), European Treaty Series No 164, Strasbourg, 1997.
6. Council of Science Editors. Editorial Policy Statements, Wheat Ridge, CO, 2010.
7. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for biomedical research involving human subjects. Geneva, CIOMS, 2002.
8. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for epidemiological studies. Geneva, CIOMS, 2008.
9. Djurskyddsförordning (SFS 1988:539).
10. Djurskyddslag (SFS 1988:534).
11. European Code of Conduct for Research Integrity Revised Edition. ALLEA, All European Academies, Berlin 2017.
12. European Science Foundation. Research Integrity: global responsibility to foster common standards.
ORI-ESF Science Policy Briefing 30, Strasbourg, 2007.
13. Hälso- och sjukvårdslag (SFS 1982:763).
14. Lag om biobanker i hälso- och sjukvården med mera (SFS 2002:297).
15. Lag om etikprövning av forskning som avser människor (SFS 2003:460).
16. Lag om genetisk integritet med mera (SFS 2006:351).
17. Läkemedelsverkets föreskrifter om kliniska läkemedelsprövningar på människor (LVFS 2011:19).
18. Offentlighets- och sekretesslag (SFS 2009:400).
19. Office of Research Integrity (ORI). Federal Research Misconduct Policy. Federal Register: December 6, 2000, Volume 65, Number 235, Notices, Page 76260–76264.
20. Organisation for Economic Co-operation and Development (OECD). Best Practices for Ensuring Scientific Integrity and Preventing Misconduct. Paris, OECD, 2007.
21. Patientdatalag (SFS 2008:355).
22. Personuppgiftslag (SFS 1998:204).
23. Sveriges universitets- och högskoleförbund (SUHF), Riktlinjer för hantering vid universitet och högskolor av frågor om vetenskaplig ohederlighet. Stockholm, SUHF, 1997.
24. The International Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). E6(R1): Good clinical practice: consolidated guideline, adopted by CPMP, July 1996, issued as CPMP/ICH/135/95/Step5, Geneva, 1996.
25. Tryckfrihetsförordning (SFS 1949:105).
26. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, latest revision by the WMA General Assembly, Seoul 2013. Ferney-Voltaire, France, World Medical Association, 2013.
Reading tips
1. Alexius Borgström, Katarina, Djuren, läkarna och lagen: en rättslig studie om djurförsöksetik. Uppsala, Iustus förlag, 2009.
2. Baggni, Julian & Fosl, Peter S., The ethics toolkit. A compendium of ethical concepts and methods.
Oxford, Blackwell, 2007.
3. Beauchamp, Tom L. & Childress, James F., Principles of biomedical ethics. Oxford & New York, Oxford University Press, (1979), Sixth Edition, 2008.
4. Bühler, Axel, (ed) Hermeneutik. Heidelberg, Synchron, 2003.
5. Cavalieri, Paola & Singer, Peter (eds.) The Great Ape Project: Equality Beyond Humanity. New York, St.
Martin’s Press, 1994.
6. Chalmers, Alan F., Vad är vetenskap egentligen? Nora, Nya Doxa, 2003.
7. Coughlin, Steven S. & Beauchamp, Tom L. & Weed, Douglas L. (eds), Ethics and epidemiology. Oxford
& New York, Oxford University Press, 2009.
8. Egonsson, Dan, Filosofiska essäer om människovärde. Falun, Nya Doxa, 1999.
9. Emanuel, Ezekiel J., et al., The Oxford textbook of clinical research ethics. Oxford & New York, Oxford University Press, 2008.
10. Fleischhauer, Kurt & Hermerén, Göran, Goals of Medicine in the Course of History and Today. A&W International, Stockholm, 2006.
11. Forsman, Birgitta, Forskningsetik: en introduktion. Lund, Studentlitteratur, 1997.
12. Forsman, Birgitta, Vetenskap och moral. Nora, Nya Doxa, 2002.
13. Forsman, Birgitta, Etik i biomedicinsk forskning: En orientering. Lund, Studentlitteratur, 2005. Forsman, Birgitta, Forskningsfusk och vetenskaplig oredlighet. Lund, Enheten för medicinsk etik, 2006.
14. Forsman, Birgitta, Forskares frihet: Om makt och moral. Lund, Studentlitteratur, 2009.
15. Föllesdal, Dagfinn & Wallöe, Lars & Elster, Jon, Argumentationsanalys, språk och vetenskaps- filosofi.
Stockholm, Thales, 2001.
16. Gilje, Nils & Grimen, Harald, Samhällsvetenskapernas förutsättningar. Göteborg, Daidalos, 1993, tredje upplagan 2007.
17. Görman, Ulf & Andrén, Carl-Gustaf & Hermerén, Göran, Att forma vår framtid: bioteknikens möjligheter och problem. Lund, Nordic Academic Press, 2009.
18. Hansson, Mats G., Integritet. I spänningen mellan avskildhet och delaktighet, Stockholm, Carlsson Bokförlag, 2006.
19. Helgesson, Gert, Forskningsetik för medicinare och naturvetare, Lund, Studentlitteratur, 2006.
20. Hermerén, Göran, Kunskapens pris: forskningsetiska problem och principer i humaniora och samhällsvetenskap. Stockholm, Swedish Science Press & HSFR, 1986, andra upplagan 1996.
21. Hermerén, Göran, ”Vi kommer aldrig att ha forskat färdigt kring de etiska problemen”. Praktik & Teori, 2007, 2:44–51.
22. Hermerén, Göran, ”Challenges in the Evaluation of Nanoscale Research: Ethical Aspects”. Nano Ethics, 2007, 1:223–237.
23. Hermerén, Göran, Hug, Kristina (red). Translational Stem Cell Research: Issues Beyond the Debate on the Moral Status of the Human Embryo. New York, Springer, 2010.
24. Karlsson, Fredrik, Weighing Animal Lives – a Critical Assessment of Justification and Prioritization in Animal-Rights Theories. Uppsala, Acta Universitatis Upsaliensis, 2009.
25. Klareskog, Lars & Rönnelid, Johan & Lundberg, Karin & Padyukov, Leonid & Alfredsson, Lars,
”Immunity to citrullinated proteins in rheumatoid arthritis.” Annual Review of Immunology, 2008, 26:651–675.
26. Kodish, Eric (ed), Ethics and research with children. A case-based approach. Oxford & New York, Oxford University Press, 2005.
27. Kuhn, Thomas S., De vetenskapliga revolutionernas struktur (1962). Stockholm, Thales, andra upplagan, 2009.
28. Loue, Sana, Textbook of research ethics. Theory and practice. Dordrecht, Kluwer, 2000.
29. Lynøe, Niels, Mellan cowboyetik och scoutmoral: medicinsk forskningsetik i praktiken. Stockholm, Liber, 1999.
30. Lynøe, Niels & Juth, Niklas, Medicinska etikens ABZ. Stockholm, Liber, 2009.
31. Macklin, Ruth, Double standards in medical research in developing countries. Cambridge, Cambridge University Press, 2004.
32. Merton, Robert, ”The Normative Structure of Science” (1942), in Merton, R., The Sociology of Science:
University of Chicago Press, 1973.
33. Murphy, Timothy, F., Case Studies in Biomedical Research Ethics. Cambridge, Mass., MIT Press, 2004.
34. Myrdal, Janken, Spelets regler i vetenskapens hantverk: Om humanvetenskap och naturvetenskap.
Stockholm, Natur & Kultur, 2009.
35. Newman, W. Lawrence, Social Research Methods, Qualitative and Quantitative Approaches. 5th edition.
Boston etc, Pearson Education, 2003.
36. Pence, Gregory E., Classic Cases in Medical Ethics. New York, McGraw Hill, 2000.
37. Perel, Pablo, & Roberts, Ian & Sena, Emily & Wheble, Philipa & Briscoe, Catherine & Sandercock, Peter
& Macleod, Malcolm & Mignini, Luciano E. & Jayaram, Pradeep & Khan, Khalid S., ”Comparison of Treatment Effects between Animal Experiments and Clinical Trials: Systemic Review”. British Medical Journal, 2007, 334 (7586):197.
38. Petersson, Bo, Forskning och etiska koder. Nora, Nya Doxa, 1994.
39. Petersson, Bo, Forskningsetisk vägning. Forskningens värde, Linköping, Centrum för tillämpad etik, 1999.
40. Popper, Karl, Conjectures and refutations: The growth of scientific knowledge (1934), London, Routledge, 2002.
41. Pryor, Erica R. & Habermann, Barbara & Broome, Marion E.,”Scientific Misconduct from the
Perspective of Research Coordinators: A National Survey”. Journal of Medical Ethics, 2007, 33; 6:365–
369.
42. Rydén, Lars (red), Etik för forskare. En antologi med utgångspunkt i arbetet med Uppsalakodexen.
Stockholm, UHÄ, 1990.
43. Snyder, Peter J. & Mayes, Linda C. & Spencer, Dennis D., Science and the media: Delgado’s brave bulls and the ethics of scientific disclosure. London, Academic Press, Elsevier, 2009.
44. de Vries, Raymond & Anderson, Melissa S. & Martinson, Brian C., ”Normal misbehavior: Scientists talk about the ethics of research”, Journal of Empirical Research on Human Research Ethics, 2006, 1; 1:43–
50.
45. de Vries, Raymond & Anderson, Melissa S. & Crain, A. Lauren & Martinson, Brian C., ”Scientists’
perceptions of organizational justice and self-reported misbehaviors”, Journal of Empirical Research on Human Research Ethics, 2006, 1; 1:51–66.
46. Wells, Frank & Farthing, Michael, Fraud and misconduct in biomedical research. London, Royal Society of Medicine Press Ltd, 2008.
47. Wendler, David, The ethics of pediatric research, Oxford & New York, Oxford University Press, 2010.
Laws, ordinances, directives
1. Arkivlag (SFS 1990:782). Arkivförordning (SFS 1991:446).
2. Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. European Community, Brussels, 2005.
3. Djurskyddslag (SFS 1988:534). Djurskyddsförordning (SFS 1988:539).
4. Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the
approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.
5. Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes.
6. Förordning om etikprövning av forskning som avser människor (SFS 2003:615).
7. Förordning om utsättning av genetiskt modifierade organismer i miljön (SFS 2002:1086).
8. Förordning om innesluten användning av genetiskt modifierade organismer (SFS 2000:271).
9. Förordning med instruktion för regionala etikprövningsnämnder (SFS 2007:1069).
10. Förordning med instruktion för Centrala etikprövningsnämnden (SFS 2007:1068).
11. Lag om biobanker i hälso- och sjukvården med mera (SFS 2002:297). Förordning (2002:746) om biobanker i hälso- och sjukvården med mera.
12. Lag om etikprövning av forskning som avser människor (SFS 2003:460).
13. Lag om genetisk integritet med mera (SFS 2006:351).
14. Läkemedelslag (SFS 2015:315).
15. Offentlighets- och sekretesslag (SFS 2009:400).
16. Patientdatalag (SFS 2008:355).
17. Personuppgiftslag (SFS 1998:204).
18. Personuppgiftsförordning (SFS 1998:1191).
19. Ändring i Centrala försöksdjursnämndens föreskrifter (LSFS 1988:45) om den etiska prövningen av användningen av djur för vetenskapliga ändamål med mera (SJVFS 2008:70).
20. Strålsäkerhetsmyndighetens föreskrifter om allmänna skyldigheter vid medicinsk och odontologisk verksamhet med joniserande strålning (SSMFS 2008:35).
21. Tryckfrihetsförordning (SFS 1949:105).
Declarations, guidelines, reports
1. 2nd World Conference on Research Integrity. Singapore Statement on Research Integrity, Singapore, 2010.
2. Berlin Declaration on Open Access to Knowledge in the Sciences and Humanities. Berlin, 2003. Bohlin, Alf, Offentlighet & sekretess i myndighetsforskningsverksamhet. Riksarkivet, 1997:2.
3. Brambell, Rogers, F.W. (Chairman), Report of the Technical Committee to enquire into the Welfare 4. of Animals kept under Intensive Livestock Husbandry Systems, London, HMSO, 1965.
5. Centrala försöksdjursnämnden, Författningar, allmänna råd och anvisningar om användningen av djur för vetenskapliga ändamål. Stockholm, CFN:s skriftserie: 45, 2002.
6. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, (Oviedo Convention), European Treaty Series No 164, Strasbourg, 1997.
7. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for biomedical research involving human subjects. Geneva, CIOMS, 2002.
8. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for epidemiological studies. Geneva, CIOMS, 2008.
9. Council of Science Editors. Editorial Policy Statements, Wheat Ridge, CO, Council of Science Editors, 2010.
10. Danish Committees on Scientific Dishonesty, Annual Report. Copenhagen, Danish Research Agency, 1993–.
11. Den nasjonale forskningsetiske komité for naturvitenskap og teknologi (NENT), Forskningsetiske retningslinjer for naturvitenskaplig teknologi. Oslo, 2007.
12. Djurförsöksetiska utredningen, Etisk prövning av djurförsök: delbetänkande (SOU 2002:86). Stockholm, Fritzes offentliga publikationer, 2002.
13. European Commission, European Research Area, Science in Society, European Textbook on Ethics in Research. EUR 24452 EN, Luxembourg Publication Office of the European Union 2010.
14. European Commission, European Research Area, Science in Society, Syllabus on Ethics in Research, Addendum to the European Textbook on Ethics in Research. EUR 24451 EN, Luxembourg Publication Office of the European Union 2010.
15. European Science Foundation. Research Integrity: global responsibility to foster common standards.
ORI-ESF Science Policy Briefing 30, Strasbourg, 2007.
16. Forsman, Birgitta, Begrepp om forskningsfusk, rapport till Vetenskapsrådet, 2007.
17. Hermerén, Göran, Hanteringen av integritetskänsligt forskningsmaterial, Vetenskapsrådet, 2007.
International Committee of Medical Journal Editors (ICMJE). Uniform Requirements for Manuscripts Submitted to Biomedical Journals, (Vancouver Rules), ICMJE, updated 2010.
18. Jordbruksverket, Användningen av försöksdjur i Sverige under 2008. Rapport, Dnr: 31-502/09.
19. Justitiedepartementet, Offentlighet och sekretess hos det allmänna, 2009.
20. Livsmedelsverket, Läkemedelsförmånsnämnden, Läkemedelsverket, Statens beredning för medicinsk utvärdering, Smittskyddsinstitutet, Socialstyrelsen och Statens folkhälsoinstitut, Hantering av jäv, intressekonflikter och bindningar när externa experter anlitas, 2008.
21. National Science Foundation (NSF), Research Misconduct Regulation, Key Regulations 45 CFR 689, 1982.
22. Office of Research Integrity (ORI), ORI Annual Report 2007, Rockville, ORI, 2008.
23. Office of Research Integrity (ORI), ORI sample policy and procedures for responding to research misconduct allegations, Rockville, U.S. Department of Health and Human Services, 2009.
24. Office of Research Integrity (ORI), Federal Research Misconduct Policy. Federal Register: December 6, 2000, Volume 65, Number 235, Notices, Page 76260–76264.
25. Organisation for Economic Co-operation and Development (OECD). OECD Principles and Guidelines for Access to Research Data from Public Funding. Paris, OECD, 2007.
26. Organisation for Economic Co-operation and Development (OECD), Investigating research misconduct allegations in international collaborative research projects. A practical guide, Paris, OECD, 2009.
27. Riksarkivet, Om gallring – från utredning till beslut. Rapport, 1999:1.
28. Sveriges universitets- och högskoleförbund (SUHF), Riktlinjer för hantering vid universitet och högskolor av frågor om vetenskaplig ohederlighet. Stockholm, SUHF, 1997.
29. Sveriges universitets- och högskoleförbund (SUHF), Övergripande principer för offentlighet och sekretess i integritetskänslig forskning. SUHF, 2006.
30. Sveriges universitetslärarförbund (SULF), Etiska riktlinjer för universitetslärare, 2005.
31. The International Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). E6(R1): Good clinical practice: consolidated guideline, adopted by CPMP, July 1996, issued as CPMP/ICH/135/95/Step5, Geneva, 1996.
32. Uppsala universitet, Hantering av allmänna handlingar vid universitetet. Tredje upplagan, 2009.
33. Vetenskapsrådet, Jävspolicy för Vetenskapsrådet, 2014.
34. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, latest revision by the WMA General Assembly, Seoul 2013. Ferney-Voltaire, France, World Medical Association, 2013.