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



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Translated from Norwegian

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

Submitted June 30, 2006

To Rikshospitalet – Radiumhospitalet MC and the University of Oslo
The investigation committee appointed on 18 January 2006 hereby submits its report.
The report is unanimous.

Oslo, June 30, 2006


Anders Ekbom

Chair




Gro E M Helgesen

Aage Tverdal



Tore Lunde

Stein Emil Vollset


----


Sigmund Simonsen

Secretary



NOTE: THIS DOCUMENT IS An english TRANSLATION of the norwegian report. Only the norwegian version is authentic. IN THE EVENT OF ANY conflict, ambiguity or discrepancy between the Norwegian Original and the English translation, the Norwegian Original shall prevail. No liability can be accepted for reliance on the english translation.

Contents

1 Summary 5

1.1 Appointment 5

1.2 The investigation 5

1.3 Findings 5

1.4 Criticism, possible explanations and preventive measures 7

1.5 The Commission's Report – an overview 8



2 The Commission’s appointment, terms of reference and method of work 10

2.1 Appointment of the investigation Commission 10

2.2 The Commission’s composition 10

2.3 The Commission’s terms of reference 10

2.4 The legal status of the Commission, legal framework, procedural rules, and principles for the investigative process 11

2.4.1The Commission’s legal status 11

2.4.2Impartiality and independence 12

2.4.3Legal measures 13

2.4.4The duty to clarify the case principle and the sound procedure principle 13

2.4.5Contradiction 13

2.4.6Requirements of proof and thresholds for criticism 14

2.4.7 The presumption of innocence 15

2.4.8Publicity 15

2.5 The Commission’s relation to the terms of reference 16

2.6 In more detail about the Commission’s method of working 17

2.6.1In general 17

2.6.2Meeting activity 17

2.6.3Retrieval of information 17

2.6.4Good scientific practice, norm deviation and dishonesty 19

3. Regulation of medical research 21

3.1 Overview of the applicable set of rules 21

3.2 Different degrees of norm deviation, guilt and blameworthiness 24

3.3 Personal liability and overall system responsibility 25

3.4 The application of the rules in time 27

3.5 In particular about authorship 28

3.5.1 Some points of departure 28

3.5.2The Vancouver rules for medical publication 29

3.5.3 The relation of medical research to the Vancouver rules 33

3.5.4 The author responsibility 35

3.6 Retraction of invalid publications 35

3.7 In detail on education of researchers/training of researchers and the supervisor role 36

3.8 Retention of research material – obligation and right 40

3.8.1 The problem at issue 40

3.8.2 The retention obligation 40

3.8.3Right of retention and management 42



4. Clarification of the facts 43

4.1 The cause – the Lancet article 43

4.2 The PhD degree project relating to oral cancer 45

4.2.1Introduction 45

4.2.2The subject matter of the doctor degree project 45

4.2.3The organization of the PhD project 46

4.2.4Advance assessment of the PhD project 49

4.2.5Reporting and publication of the PhD work 54

4.2.6The patient material – an overview 55

4.2.7Representation of the raw material in the publications 59

4.2.8Other errors and flaws 83

4.2.9 Summary 87

4.2.10 Main conclusion 89

4.3 After the presentation of the thesis 90

4.4 Other publications 92

5. Possible explanations 97

5.1 Introduction 97

5.2 The PhD project and further research 97

5.3 In particular about the NCI application and Lancet article 101

5.4 Questions are raised in relation to the ploidy classifications 105

5.5 External factors 106

5.6 Flaws in sets of regulations and similar formal types of control 107

6. Possible consequences 109

6.1 Reflections on consequences for research 109

6.2 Possible harmful consequences regarding the treatment of patients, etc. 110

7. Criticizable circumstances 111

7.1 Introductory remarks 111

7.2 Criticism of individual persons 112

7.2.1 Jon Sudbø 112

7.2.2Albrecht Reith 114

7.3 Criticism of institutions 115

7.3.1 The Rikshospitalet – Radiumhospitalet MC 115

7.3.2The University of Oslo – The Odontology 117

7.3.3The University of Bergen – Gade’s Institute 117

7.3.4The Cancer Registry 117

7.4 General remarks 118

8. Recommendations 120

8.1. The institutions 120

8.2 The journals 121

8.3 The Commission’s concluding remark 122



Annexes 123

Annex 1: Jon Sudbø’s publication list 124

Annex 2: Evolvement of the authorship criteria 127

Annex 3: Files and lists which the Commission has used in the investigation of the articles in New England Journal of Medicine 2001 and 2004 132

Annex 4: Table 134

Annex 5: The Dishonesty Committee’s Guidelines 138

Medical words and expressions 140

Statutes and regulations referenced in the report 143

List of literature 144



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