7.3.1 The Rikshospitalet – Radiumhospitalet MC
The Commission has found reason to criticize the Rikshospitalet/Radiumhospitalet MC represented by its general management regarding a series of circumstances. The Commission’s basis is that Sudbø during his entire scientific career primarily was associated with the Radiumhospitalet, which then had the overall everyday responsibility for his research which was performed under the auspices of the Radiumhospitalet, cf section 4.2. It should be noted that prior to January 1, 2002, the State represented by the Ministry of Health, was responsible for the Radiumhospitalet. As from and including January 1, 2002, the Radiumhospitalet became a separate medical center and thus a separate legal entity. As from and including January 1, 2005, the Rikshospitalet MC and the Radiumhospitalet MC were merged into one medical center and legal entity: The Rikshospitalet – Radiumhospitalet MC. The medical center has not been given the opportunity to respond to this criticism, cf section 2.4.6.
In introduction, the Commission would emphasize that this criticism is not based on comprehensive investigations of the management, but rather on more or less clear impressions which the Commission is left with after investigating a specific personnel matter. The Commission nevertheless finds reason to mention these impressions.
When a research institution, which the MC is, makes provisions for research at the institution, it must be prepared to carry the full responsibility for the individual researcher and the relevant research project, regardless of whether others also have an independent responsibility. Patients and others who relate to the MC, including collaborating institutions, must be able to expect that researchers at the MC work on behalf of the same MC, and that the MC has the overall responsibility.
The medical center must therefore suffer criticism for what appears as inadequate training, management and control of Jon Sudbø’s and other employees’ research activities at the institution. This has probably been a contributing factor to the dishonest research being able to take place and be carried on for such a relatively long time.
Several researchers at the institution have described situations from earlier periods which in the Commission’s opinion indicate a disturbing lack of awareness of the prevailing rules for good research practice. This applies in particular to rules on secrecy, protection of personal data, authorship and advance assessments of research projects which are the rules which have been particularly relevant in this case. Furthermore, the distribution of responsibility regarding the institution’s research have been unclear
and too much of the activity has been left to the individual researcher. Unacceptable matters which in fact were pointed out, and which could have brought the dishonest research to light, were not followed up and managed in a satisfactory way.
Here should be noted that there is no lack of good intentions. The management has had a very clear attitude as regards its own responsibility and high expectations to its own employees. In conversations with the Commission, the management referred to internal work instructions and other measures as for example the so-called Protocol Committee and coordinating office for research, which is meant to contribute to the implementation of rules and regulations and enhanced research practice. The management also had a very clear attitude regarding expectations that the employees comply with all statutes, regulations and work instructions, including the Helsinki Declaration as well as the Vancouver Rules. However, the Commission is left with an impression that these measures have not been followed up well enough. By this, an attitude among the employees has been allowed to develop to the effect that after all it did not matter so much with for example the duty of secrecy, recommendations from the Regional Committee for Medical Research Ethics and practicing of the authorship criteria. Several people stated to the Commission that the Vancouver Rules are not binding for them – they are only guidelines, whereas the management stated that they evidently enough are binding on their employees. The management must assume the responsibility for this discrepancy and confusion.
The Commission has the impression that circumstances have become/are becoming better. Insufficient follow up of research by management was hardly an unusual phenomenon at some Norwegian research institutions some years ago. Traditionally, researchers have worked very freely, both at universities and Norwegian hospitals. Clinicians have been encouraged to carry on research, but sufficient awareness related to the different roles and partly different requirements put to them has probably not been sufficient, neither on the part of researchers nor management. Insufficient and failing routines, and an insufficient system for notifying irregularities, have been an unfortunate combination for the Radiumhospitalet. The medical research community is thus in a transition phase as regards the organization and formalities relating to medical research. The Commission believes that this specific case has been an eye-opener for this as well as for other research institutions, and will probably contribute to speeding up this development process.
The Commission nevertheless finds reason to maintain the criticism of the Rikshospitalet/Radiumhospitalet MC. The criticizable circumstances can be summarized as:
Insufficient advance control and organization of Sudbø’s PhD project, including specification of distribution of responsibility.
Insufficient training and consciousness-raising of Sudbø and other employees about the rules for handling patient material, advance assessment of research projects and authorship.
The University of Oslo – The Odontology
The Commission finds reason to level a certain criticism against the University of Oslo, the Faculty of Odontology, for delivering patient material and data from the Odontology to Jon Sudbø and Albrecht Reith without the existence of participant’s consents or dispensations from the duty of secrecy as required at that time, cf section 4.2.7, cf section 4.2.4. The delivery of data therefore appears as a breach of the regulations in force at that time. The University of Oslo has not been given the opportunity to respond to this criticism, cf section 2.4.6.
In this context is noted that Jon Sudbø was employed in a 20% position only at the University of Oslo from May 2, 2005 until the beginning of 2006 and also that the University during this period had a more secondary general responsibility for Jon Sudbø’s research activities, compared with the Rikshospitalet/Radiumhospitalet MC.
The University of Bergen – Gade’s Institute
The Commission has found reason to level a certain criticism against the University of Bergen, Department of Pathology, “Gade’s Institute”, for not having made sure that Jon Sudbø and Albrecht Reith had obtained consent from the patients or dispensation from the duty of secrecy when patient material and data were delivered to them, cf section 4.2.7, cf section 4.2.4. The delivery of data thus appears as a breach of the regulations in force at that time. The University of Bergen has not commented on the Commission’s draft of criticism.
The Cancer Registry
The Commission considered whether there was reason to level a certain criticism against the Cancer Registry for not having made sure that Jon Sudbø and Albrecht Reith had obtained consent from the patients or dispensation from the duty of secrecy when cancer registry data connected to their patient data in 1996 were delivered to them, cf section 4.2.7, cf section 4.2.4. The framework concession of December 9, 1985, item 4.3 no. 2, third dash line, states that the delivery of information for research purposes was conditional on observance of the rules on secrecy, where appropriate after dispensation. No dispensation for the relevant delivery was granted.
The Cancer Registry was notified that the Commission considered to level a certain criticism on this basis and made use of its right to comment on an earlier draft of section 7.3.4 of the report. In a letter to the Commission dated June 20, 2006, the Cancer Registry asserted that the draft criticism is based on an erroneous conception of the Cancer Registry’s different roles. The Cancer Registry asserts that it understood Jon Sudbø’s request of February 20, 1996, as a routine request for follow-up data for patients at the Radiumhospitalet, Department of Pathology, which did not require advance permission, such as for example dispensation from the duty of secrecy, see in more detail section 4.2.7.
The Commission has considered the Cancer Registry’s comments and compared them with the information given in Jon Sudbø’s letter of February 20, 1996 to the Cancer Registry, quoted in section 4.2.7, and other information in the case. On that background, the Commission finds that it appears from the letter that it is a question of a research project, something which the Cancer Registry should have understood. The delivery of data then appears as a breach of the licence conditions.