Research ethics is an obvious part of every researcher’s life. For some areas like health informatics, the multidisciplinarity and interdisciplinarity of the field makes it necessary to pay attention to ethical guidelines, acts/laws, and principles from both medicine and health science, science and technology, and social sciences and humanities. If you know where to look and what to look for, it is easy to find relevant information about research ethics. However, studies have indicated that we cannot take this knowledge for granted. If you do clinical trials, you have to apply to the Regional Committees for Medical and Health Research Ethics (REK) for approval. If you do studies with patients that do not imply any treatment or improvement of medical procedures, i.e., are not covered by the Health Research Act, you need to contact the “personvernombudet” (patient data protection ombud/officer) to get approval for involving patients. But for many research projects in health informatics, these kinds of approvals are not necessary. Some PhD students take part in large project with an existing approval by REK. This means that they probably have not been involved in writing the research protocol and applying for REK approval. As a consequence, the do not know this process very well. For most researchers, ethical guidelines are not something they have good knowledge of. A small inquiry among PhD students in science and technology at the University of Tromsø – The Arctic University of Norway, showed that ethical guidelines were vaguely known. This paper gives an overview of what kind of ethical guidelines, acts and ethical principles a researcher in a multiand interdisciplinary field as health informatics needs to know and pay attention to. Norwegian laws and regulations ae used to illustrate what kind of information that is needed .
ethical guidelines, research ethics, health informatics.
1. Procter, R. Dr. (Editor, Health Informatics Journal, Edinburgh, United Kingdom). Definition of health informatics [Internet]. Message to: Virginia Van Horne (Content Manager, HSR Information Central, Bethesda, MD). 2009 Aug 16 [cited 2009 Sept 21]. [1 paragraph]. Available from: https://www.nlm.nih.gov/.
2. Hartvigsen, G., Rekk opp hånden alle som kjenner til forskningsetiske retningslinjer. (“Raise your hand all who are familiar with research ethics guidelines”). Forskningsetikk 2013. 13(3): p. 22.
3. NENT, Guidelines for research ethics in science and technology. 2007, De nasjonale forskningsetiske komiteer: Oslo.
4. NESH, Guidelines for research ethics in the social sciences, law and the humanities. 2006, Oslo: De nasjonale forskningsetiske komiteer.
5. Kunnskapsdepartementet, “Lov om behandling av etikk og redelighet i forskning.” (“Act on ethics and integrity in research”) Act of 30 June 2006 No. 56.
6. Helse- og omsorgsdepartementet, “Lov om medisinsk og helsefaglig forskning (helseforskningsloven).” (ACT 2008-06-20 no. 44: “Act on medical and health research (the Health Research Act)”) Norwegian Act of 1.7.2009.
7. WMA. WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. 2013; Available from: http://www.wma.net/en/30publications/10policies/b3/index.html.
8. Kunnskapsdepartementet, Ot.prp. nr. 58 (2005-2006) “Om lov om behandling av etikk og redelighet i forskning” (White paper no. 58 (2005-2006) “On the Act on ethics and integrity in research”). M.o.E.a. Research, Editor. 2006: Oslo.
9. De nasjonale forskningsetiske komiteene. Forskningsetisk bibliotek. [cited 1.2.2016; Av. from: https://www.etikkom.no/FBIB/.
10. European Commision, European Textbook on Ethics in Research. Vol. EUR 24452 EN. 2010, Brussels, Belgium: European Commision, Directorate-General for Research.
11. ICMJE. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. 2015; Available from: http://www.icmje.org/icmje-recommendations.pdf.
12. Oviedo. 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. CETS No. 164. Oviedo, 4.IV.1997. 1997 1.2.2016; Available from: http://www.coe.int/nb/web/conventions/full-list/-/conventions/treaty/164.
13. NEM, Veiledning for forskningsetisk og vitenskapelig vurdering av kvalitative forskningsprosjekt innen medisin og helsefag. Laget av Den nasjonale forskningsetiske komité for medisin og helsefag (NEM), 2009. 2010, Oslo: De nasjonale forskningsetiske komiteer.
14. NEM, Payment for research participants in medical and health research. (“Betaling til deltakere i medisinsk eller helsefaglig forskning.”), in En veiledning laget av Den nasjonale forskningsetiske komité for medisin og helsefag (NEM). 2009, De nasjonale forskningsetiske komiteer: Oslo.
15. NEM, Guidelines for the inclusion of women in medical research. (“Retningslinjer for inklusjon av kvinner i medisinsk forskning.”) in Laget av Den nasjonale forskningsetiske komité for medisin og helsefag (NEM). 2001, De nasjonale forskningsetiske komiteer: Oslo.
16. NEM, Clinical trials of medicinal products. Guidelines for ethical evaluation og post-marketing studies. (“Klinisk utprøving av legemidler. Retningslinjer for vurdering av post-marketing studier.”), in Utarbeidet av Den nasjonale forskningsetiske komité for medisin. 2005, De nasjonale forskningsetiske komiteer: Oslo.
17. NEM, Guidelines for research on persons with impaired informed consent capacity. (“Redusert samtykkekompetanse i helsefaglig forskning. Retningslinjer for inklusjon av voksne personer med manglende eller redusert samtykkekompetanse i helsefaglig forskning") in Utarbeidet av Den nasjonale forskningsetiske komité for medisin (NEM). 2005, De nasjonale forskningsetiske komiteer: Oslo.
18. REC. Regional Committees for Medical and Health Research Ethics (REC). [cited 1.2.2016; Av from: https://helseforskning.etikkom.no/.
19. U.S. National Institutes of Health. ClinicalTrials.gov. [cited 1.2.2016; Available from: https://clinicaltrials.gov/.
20. NESH, Ethical guidelines for Internet research. (“Etiske retningslinjer for forskning på Internett”) in The National Committee for Research Ethics in the Social Sciences and the Humanities (NESH). 2014, De nasjonale forskningsetiske komiteer: Oslo.
21. The Norwegian National Research Ethics Committees. Am I obligated to submit my research project to a committee for research ethics? [cited 2016 1.2.2016]; Available from: https://www.etikkom.no/en/our-work/frequently-asked-questions/am-iobligated-to-submit-my-research-project-to-a-committee-for-researchethics/.
22. The Norwegian National Research Ethics Committees. General guidelines for research ethics. 2014 [cited 1,2,2016; Available from: https://www.etikkom.no/en/ethical-guidelines-forresearch/general-guidelines-for-research-ethics/.
23. University of Oslo. Guidelines for ethical practice in research: UiO’s 10 Commandments. 2007 [cited 1.2.2016; Available from: http://www.uio.no/forskning/om-forskningen/etikk/10-bud-for-for-godforskningsetikk.html.
24. University of Bergen. 10 etiske regler for Universitetet i Bergen.
2006 [cited 1.2.2016; Available from: https://regler.app.uib.no/regler/Del-2-Forskning-utdanning-ogformidling/2.1-Forskning/2.1.4-Etikk-og-personvern-iforskning/Reglement-og-retningslinjer-fastsatt-av-universitetsstyret/10-
etiske-regler-for-Universitetet-i-Bergen.
25. Nuernberg Military Tribunals, Trials of War Criminals before the Nuernberg Military Tribunals under Control Council Law No. 10. 1949, U.S. Government Printing Office: Washington, D.C. p. 181-182.
26. University of Tromsø - The Arctic University of Norway. Etiske retningslinjer for veiledning - Ethical Guidelines Supervision. 2011 [cited 1.2.2016; Available from: https://uit.no/om/enhet/artikkel?p_document_id=200332&p_dimension_id=88199&men=42429.
27. University of Tromsø - The Arctic University of Norway. Etiske retningslinjer for veiledning ved Universitetet i Tromsø. 2004 [cited 1.2.2016; Available from: https://uit.no/Content/171815/Etiskeretningslinjer for veiledere - 200305499-15.pdf.
28. University of Tromsø - The Arctic University of Norway. Ethical guidelines for supervision at the University of Tromsø. 2004 [cited 1.2.2016; Available from: https://uit.no/Content/171816/Etiskeretningslinjer for veiledere - engelsk.pdf.
29. Goodman, K.W., Addressing Ethical Issues in Health Information Technology. Cambridge Quarterly of Healthcare Ethics, 2015. 24(3): p. 252-254.
30. Eysenbach, G. Another plagiarist bites the dust (anatomy of a plagiarizing paper). 2008 Posted 10th March 2008 [cited 1.2.2016; Available from: http://gunthereysenbach.blogspot.no/2008/03/another-plagiarist-bites-dustanatomy.html.
31. Sox, H., Plagiarism in the Digital Age. Office of Research Integrity Newsletter, 2012. 20(3): p. 1, 6.
32. Hartvigsen, G., Plagiering – det dummeste du kan gjøre som forsker? (“Plagiarism - the stupidest thing you can do as a researcher?”) Forskningsetikk, 2012. 12(2-3): p. 26.
33. Fossheim, H.J. and H. Ingierd. Miniguide til undervisningsopplegg. 2014 [cited 1.2.2016; Available from: https://www.etikkom.no/FBIB/Ressurser/Miniguide-tilundervisningsopplegg-/.
34. RREE. Resources for Research Ethics Education. Research Ethics Program 2013 [cited 1.2.2016; Available from: http://research-ethics.net/.
35. UNESCO. Global Ethics Observatory (GEObs). 2016 [cited 1.2.2016; Available from: http://www.unesco.org/new/en/social-andhuman-
sciences/themes/global-ethics-observatory/access-geobs/.
36. UNESCO, Ethics of Science and Technology at UNESCO. 2008, Division of Ethics of Science and Technology Sector for Social and Human Sciences United Nations Educational, Scientific and Cultural Organization (UNESCO): Paris, France. p. 20.
37. CODEX. Rules & guidelines for research. [cited 1.2.2016; Available from: http://www.codex.vr.se/en/regler.shtml.
38. Eriksson, S., A.T. Höglund, and G. Helgesson, Do Ethical Guidelines Give Guidance? A Critical Examination of Eight Ethics Regulations. Cambridge Quarterly of Healthcare Ethics, 2008. 17(1): p. 15-29.
