Report from the Investigation Commission appointed by Rikshospitalet – Radiumhospitalet mc and the University of Oslo January 18, 2006



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Statutes and regulations referenced in the report

Bio Bank Act Lov om biobanker (LOV-2003-02-21-12).


Public Administration Act Lov om behandlingsmåten i forvaltningens saker (LOV-1967-02-10).
Research Ethics Act Lov om behandling av etikk og redelighet i forskning. (LOV-2006-06-08-71). (Ikke sanksjonert).
Medical Centers Act Lov om helseforetak m.m. (LOV-2001-06-15-93).
Health Personnel Act Lov om helsepersonell m.v. (LOV-1999-07-02-64).
Personal Health Data Filing System Act Lov om helseregistre og behandling av helseopplysninger. (LOV-2001-05-18-4).
Medical Records Regulations Forskrift om pasientjournal. (FOR-2000-12-21-1385).
Universities and Colleges Act Lov om universiteter og høyskoler. (LOV-2005-04-01-15).
Human Rights Act Lov om styrking av menneskerettighetenes stilling i norsk rett.

(LOV-1999-05-21-0).


Freedom of Information Act Lov om offentlighet i forvaltningen. (LOV-1970-06-19-69).
Patients' Rights Act Lov om pasientrettigheter. (LOV-1999-07-02-63).
Personal Data Act Lov om behandling av personopplysninger. (LOV-2000-04-14-31).
Act relating to compensation in certain circumstances Lov om skadeserstatning. (LOV-1969-06-13-26).
Specialist Health Services Act Lov om spesialisthelsetjenesten m.m. (LOV-1999-07-02-61).
Copyright Act Lov om opphavsrett til åndsverk m.v. (LOV-1961-05-12-2).
Repealed acts
Act relating to medical practitioners Lov om leger. (LOV-1980-06-13-42).
Act relating to Personal Data Filing Systems Lov om personregistre m.m. (LOV 1978-06-09-48).
Act relating to dentists Lov om tannleger (LOV 1980-06-13 nr 43).

List of literature

Bates T, Anič A, Marušič M, Marušič A. Authorship Criteria and Disclosure of Contributors.

Comparison of 3 General Medical Journals With Different Author Contribution Forms. JAMA

2004; 292: 86–88.


Benestad HB, Laake P. Forskningsmetode i medisin og biofag. Oslo: Gyldendal, 2004.
Bentzen N, Hansen BL, Nexøe J (red.). Ph.D.-vejledning. Et idéhæfte. Købehavn, 1999.
Bergsjø P. Biomedisinske forskningsprosjekter hvor forsøk på mennesker inngår – hva er nå det?
Tidsskrift for Den norske lægeforening nr 12 1993; 113: 1443-1444.
Bhopal R et al. The vexed question of authorship: views of researchers in a British medical

faculty. BMJ 1997; 314: 1009


Bratholm A. Granskning som statlig virkemiddel for å bringe faktiske forhold eller

ansvarsforhold på rene. Lov og Rett 1986: 439.


Buskop T. Hvem har ansvaret for et forskningsprosjekt? www.forskningsjus.no, 2006.
Hoen WP, Walvoort HC, Overbeke AJPM. What Are the Factors Determining Authorship and

the Order of the Authors’ Names?, A Study Among Authors of the Nederlands Tijdschrift voor

Geneeskunde (Dutch Journal of Medicine). JAMA 1998; 280: 217–218.
Innst.O.nr.70 (2005-2006) Innstilling fra kirke-, utdannings- og forskningskomiteen om lov om

behandling av etikk og redelighet i forskning


Kwok LS. The White Bull effect: abusive coauthorship and publication parasitism. J Med Ethics

2005; 31: 554–556.


Kyvik S. Forskerutdanning. I Magnus Gulbrandsen M, Smeby JS (red). Forskning ved

universitetene. Oslo: Cappelen Akademisk forlag, 2005.

Lippman SM, Hong WK. Molecular Markers of the Risk of Oral Cancer. N Engl J Med 2001;

344: 1323-1326.


Lock S, Wells F, Farthing M eds. Fraud and Misconduct in Biomedical Research. London: BMJ

Books, 2001.


NOU 2005:1 God forskning – bedre helse. Lov om medisinsk og helsefaglig forskning som

involverer mennesker, humant biologisk materiale og helseopplysninger (helseforskningsloven).


Nylenna M, Simonsen S. Scientific misconduct: a new approach to prevention. The Lancet 2006;

367: 1882-1884.


Nylenna M. Forfatterskapskriteriene er endret. Tidsskrift for Den Norske Lægeforening 2000;

120: 1844.


Ot.prp. nr. 58 (2005-2006) Om lov om behandling av etikk og redelighet i forskning.
Pignatelli B, Maisonneuve H, Chapuis F. Authorship ignorance: views of researchers in French

clinical settings. J Med Ethics 2005; 31: 578–581.


Rennie D, Flanagin A, Yank V. The Contributions of Authors. JAMA 2000; 284: 89–91.
Rundskriv G-48/75 av 4. mars 1975 ”Regler for granskningskommisjoner”
Ruyter KW. Forskningsetikk. Oslo: Gyldendal, 2003.
Sheikh A. Publication ethics and the research assessment exercise: reflections on the troubled

question of authorship. Journal of Medical Ethics 2000; 26: 422–426.


Simonsen S, Nylenna M. Helseforskningsrett. Oslo: Gyldendal, 2005.
Sox HC. Research Misconduct, Retraction, and Cleansing the Medical Literature: Lessons from

the Poehlman Case. Annals of Internal Medicine 2006; 144: E-7–E-11.

Tranøy KE. Vitenskapen – samfunnsmakt og livsform. Oslo: Universitetsforlaget, 1986.
Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing

for Biomedical Publication – updated February 2006


Yank V, Rennie D. Disclosure of Researcher Contributions: A Study of Original Research

Articles in The Lancet. Annals of Internal Medicine 1999; 130: 661–670.




1 Rundskriv G-48/75 of March 4, 1975 ”Regler for granskningskommisjoner

2 Bratholm A. Granskning som statlig virkemiddel for å bringe faktiske forhold eller ansvarsforhold på rene [Investigation as a governmental tool to bring actual facts or responsibility relationships to light] . Lov og Rett, 1986: p. 439

3 See in more detail Skoghøy JE. Tvistemål [Civil Procedure] Oslo: Universitetsforlaget, 2001: p. 673 et seq.

4 www.pubmed.gov

5 See for example Ruyter KW. Forskningsetikk [Research Ethics]. Oslo: Gyldendal, 2003

6 See for example Benestad HB, Laake P. Forskningsmetode i medisin og biofag [Research method in medicine and bio subjects] Oslo: Gyldendal, 2004

7 See for example Simonsen S, Nylenna M. Helseforskningsrett [Health Research Law] Oslo: Gyldendal, 2005

8 NOU [Norwegian Official Reports] 2005:1: God forskning – better health [Good Research – Better Health]. Act relating to medical and health research that involves humans, human biological material and health data (the Health Research Act); Ot.prp. [Proposition to the Odelsting] no. 58 (2005-2006) On an Act relating to the dealing with ethics and honesty in research; Ruyter KW. Forskningsetikk [Research Ethics]. Oslo: Gyldendal, 2003; Benestad HB, Laake P. Forskningsmetode i medisin og biofag [Research method in medicine and bio subjects] Oslo: Gyldendal, 2004; Simonsen S, Nylenna M. Helseforskningsrett [Health Research Law] Oslo: Gyldendal, 2005

9 NOU [Norwegian Official Reports] 2005:1: God forskning – better health [Good Research – Better Health]. Act relating to medical and health research that involves humans, human biological material and health data (the Health Research Act)

10 NOU [Norwegian Official Reports] 2005:1: God forskning – better health [Good Research – Better Health]. Act relating to medical and health research that involves humans, human biological material and health data (the Health Research Act); Simonsen S, Nylenna M. Helseforskningsrett [Health Research Law] Oslo: Gyldendal, 2005; Ruyter KW. Forskningsetikk [Research Ethics]. Oslo: Gyldendal, 2003

11 The Helsinki Declaration: World Medical Association Declaration of Helsinki. Ethical Principles for Medical

Research Involving Human Subjects. Ferney-Voltaire: World Medical Association, 2004.




12 Benestad HB, Laake P. Forskningsmetode i medisin og biofag [Research method in medicine and bio subjects] Oslo: Gyldendal, 2004. Tranøy KE. Vitenskapen – samfunnsmakt og livsform [Science – community power and way of life]. Oslo: Universitetsforlaget, 1986.

13 Ot.prp. [Proposition to the Odelsting] no. 58 (2005-2006) On an act relating to the dealing with ethics and honesty in research. NOU [Norwegian Official Reports] 2005:1: God forskning – better health [Good Research – Better Health]. Act relating to medical and health research that involves humans, human biological material and health data (the Health Research Act). Simonsen S, Nylenna M. Helseforskningsrett [Health Research Law] Oslo: Gyldendal, 2005. Ruyter KW. Forskningsetikk [Research Ethics]. Oslo: Gyldendal, 2003. Benestad HB, Laake P. Forskningsmetode i medisin og biofag [Research method in medicine and bio subjects] Oslo: Gyldendal, 2004.

14 Nylenna M, Simonsen S. Scientific misconduct: a new approach to prevention. The Lancet 2006;367:1882-1884.

15 Buskop T. Hvem har ansvaret for et forskningsprosjekt? [Who is responsible for a research project?] www.forskningsjus.no. 2006.

16 Simonsen S, Nylenna M. Helseforskningsrett [Health Research Law] Oslo: Gyldendal, 2005

17 NOU [Norwegian Official Reports] 2005:1: God forskning – better health [Good Research – Better Health]. Act relating to medical and health research that involves humans, human biological material and health data (the Health Research Act)

18 In respect of this discussion, refer to, i.a., Bates T, Anič A, Marušič M, Marušič A. Authorship Criteria and Disclosure of Contributors. Comparison of 3 General Medical Journals With Different Author Contribution Forms. JAMA 2004; 292: 86–88; Bhopal R et al. The vexed question of authorship: views of researchers in a British medical faculty.BMJ 1997; 314: 1009; Hoen WP, Walvoort HC, Overbeke AJPM. What Are the Factors Determining Authorship and the Order of the Authors’ Names?, A Study Among Authors of the Nederlands Tijdschrift voor Geneeskunde (Dutch Journal of Medicine). JAMA 1998; 280: 217–218; Kwok LS. The White Bull effect: abusive coauthorship and publication parasitism. J Med Ethics 2005; 31: 554–556; Nylenna M. Forfatterskapskriteriene er endret [The authorship criteria are changed]. Tidsskrift for Den Norske Lægeforening 2000; 120: 1844; Pignatelli B, Maisonneuve H, Chapuis F. Authorship ignorance: views of researchers in French clinical settings. J Med Ethics 2005; 31: 578–581; Rennie D, Flanagin A, Yank V. The Contributions of Authors. JAMA 2000; 284: 89–91; Sheikh A. Publication ethics and the research assessment exercise: reflections on the troubled question of authorship. Journal of Medical Ethics 2000; 26: 422–426; Sox HC. Research Misconduct, Retraction, and Cleansing the Medical Literature: Lessons from the Poehlman Case. Annals of Internal Medicine 2006; 144: E-7–E-11; Yank V, Rennie D. Disclosure of Researcher Contributions: A Study of Original Research Articles in The Lancet. Annals of Internal Medicine 1999; 130: 661–670.


19 Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical

Publication – updated February 2006




20 Nylenna M. Forfatterskapskriteriene er endret [The authorship criteria are changed]. Tidsskrift for Den Norske Lægeforening 2000;120:1844


21 21 Bhopal R et al. The vexed question of authorship: views of researchers in a British medical faculty. BMJ 1997;

314: 1009




22 Pignatelli B, Maisonneuve H, Chapuis F. Authorship ignorance: views of researchers in French clinical settings. J

Med Ethics 2005; 31: 578–581.



23 Kyvik S. Forskerutdanning [Education of Researchers]. In Magnus Gulbrandsen M, Smeby JS (ed.). Forskning ved universitetene [Research at the Universities]. Oslo: Cappelen Akademisk forlag, 2005.

24 Bentzen N, Hansen BL, Nexøe J (red.). Ph.D.-vejledning. Et idéhæfte [PhD guide. An ideas booklet]. Købehavn, 1999.


25 NOU [Norwegian Official Reports] 2005:1: God forskning – better health [Good Research – Better Health]. Act relating to medical and health research that involves humans, human biological material and health data (the Health Research Act)

26 Rettens Gang [a Norwegian law reporter of court decisions in the first instance and courts of appeal] 2000, p. 1010.

27 Simonsen S, Nylenna M. Helseforskningsrett [Health Research Law] Oslo: Gyldendal, 2005

28 Horton R. Retraction—Non-steroidal anti-inflammatory drugs and the risk of oral cancer: a nested case-control

study. The Lancet 2006; 367:382, Expression of concern for Sudbø et al., J Clin Oncol 23: 1927-1933.

Journal of Clinical Oncology 2006; 24: pp. 2404; Curfman GD, Morrissey S, Drazen JM. Expression of concern:

Sudbo J et al. DNA content as a prognostic marker in patients with oral leukoplakia. N Engl J Med 2001;344:1270-8

and Sudbo J et al. the influence of resection and aneuploidy on mortality in oral leukoplakia. N Engl J Med

2004;350:1405-13.




29 Refer to, i.a., an article by Bergsjø P. Biomedisinske forskningsprosjekter hvor forsøk på mennesker inngår – hva er nå det? [Biomedical research projects of which experiments on humans form part – what would that be?] Tidsskrift for Den norske lægeforening, 1993;113: 1443-1444.


30 The Data Inspectorate. Tilsyn våren 2004 [Inspection spring 2004]. Behandling av helseopplysninger i forskning. Funn og tendenser [Treatment of health data in research. Findings and trends]. Oslo:Datatilsynet, 2004


31 List: ”Oslo_030606.xls”

32 Memo from the Cancer Registry of March 7, 2006 with annexes.

33 33 Sudbø J, Kildal W, Johannessen AC, Koppang HS, Sudbo A, Danielsen HE, Risberg B, Reith A. Gross genomic

aberrations in precancers: clinical implications of a long-term follow-up study in oral erythroplakias. J Clin Oncol.

2002 Jan 15;20:456-62.


34 Letter from the Cancer Registry to the Commission of May 9, 2006.

35 List: ”Sammenlign_kreft96_og_06xls” [”Comparison cancer96 and 06xls”]

36 List: ”Alle_ploidi_060606.xls”[”All ploidy 060606.xls”]

37 Letter from Reith to the Acting Health Director of January 11, 2001. Letter from the Norwegian Board of Health of April 17, 2001. Letter of April 23, 2001 from Reith and Sudbø to the Norwegian Board of Health.

38 Lippman S. M., Hong W. K. Molecular Markers of the Risk of Oral Cancer. N Engl J Med 2001; 344:1323-1326.


39 www.pubmed.gov

40 Sudbø J, Reith A, Florenes VA, Nesland JM, Ristimaki A, Bryne M. COX-2 -expression in striated muscle under

physiological conditions. Oral Dis 2003:313-6.




41 Dataliste: ”updated_rawdata_renamed_sudbo8.xls”

42 ”All histologic sections were subsequently reevaluated by four pathologists according to the guidelines of the

World Health Organization”;NEJM 2001 page 1272.



43 ”All specimens were coded, and DNA histograms were classified in a blinded manner by four observers”; New

England Journal of Medicine 2001



44 www.fda.gov

45 http://www.adressa.no/nyheter/sortrondelag/article499549.ece


46 NOU [Norwegian Official Reports] 2005:1: God forskning – better health [Good Research – Better Health]. Act relating to medical and health research that involves humans, human biological material and health data (Health Research Act)

47 See www.klinforsk.no. For Aker University Hospital, see www.forskningsjus.no, and for Ullevål University Hospital refer to http://www.ulleval.no/modules/module_123/news_template_avdeling.asp?iCategoryId=664


48 Taken from www.pubmed.gov Januaary 2006. Not exhaustive.

49 JJL=J.Jack Lee, AR= Albrecht Reith, JS= Jon Sudbø, HD=Håvard Danielsen, RP=Ruth Punthervold

50 Please note that these guidelines are neither entirely up to date nor exhaustive, and that more recent legislation, as for example the Bio Bank Act that came into force in the summer of 2003 is not included.

51 Mainly taken from: Nylenna M. Medisinsk ordbok [Medical Dictionary]. Oslo: Kunnskapsforlaget, 2005.

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