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

1.4 Criticism, possible explanations and preventive measures

Sudbø. The comments that Sudbø has made to the Commission in a meeting and after

having read two draft reports with attached documentation, have not given the

Commission reason to make any major changes in the preliminary conclusions drawn

during the investigation.

In compliance with the terms of reference, the Commission has posed the question

of how such – in retrospect – obvious and gross acts could have been perpetuated over

such a long period of time in collaboration with so many well-qualified coauthors/

scientists and research institutions.

The Commission points out that there will invariably be certain possibilities for a

dishonest researcher to dupe and deceive others. Another factor is that Jon Sudbø has

operated relatively independently both as a doctoral candidate and later as a researcher.

He has always maintained full and sole control of the underlying data. In that connection,

the Commission has found reason to criticize his supervisor for a lack of due diligence

and academic supervision during Sudbø's fellowship. This case has also revealed what

appears to be a systemic failure at the Norwegian Radium Hospital with respect to a lack

of supervision, training and control procedures. Another circumstance is that there has

been no formal permission or approval whatsoever of the project on the part of external

bodies, nor has anyone taken it upon themselves to arrange for or check this. In this

context, it has been noted that the institutions that contributed patient material have not

required verification of the necessary permits, e.g. dispensation from mandatory

confidentiality.

The Commission has not found indications that others, including some of the coauthors,

have been involved in the fabrication and manipulation of research data or by

other means been party to scientific misconduct. However, in good conscience and based

on cost/benefit considerations, the Commission has not perceived its task as being to

investigate less serious types of deviations from the norm. The co-authors can generally

be divided into two groups: 1) suppliers (subcontractors), and 2) higher level guarantors

(senior researchers), who to little or no degree contributed to or had knowledge of the

underlying data material. Most communication has taken place through Jon Sudbø. Thus

the co-authors have had little opportunity, as well as little reason, to check the underlying

data and each other's contributions. Such a division of labour is not uncommon for

medical publications that must necessarily be based on cooperation between researchers

with rather dissimilar professional backgrounds and tasks, and thus require that they trust

each other.

On the other hand, the Commission has pointed out certain factors to which

several people should have reacted, be they co-authors, supervisors, superiors, opponents,

colleagues or others. Since there have been a number of less serious mistakes on the part

of several people that must be viewed in context (collective and cumulative mistakes), the

Commission has found reason to view this as systemic failure, where the responsibility

rests with the institutions.

In light of this, the Commission has recommended that the institutions take more

responsibility for raising awareness and instructing their researchers about the rules that

apply, and that they engage in at least a minimum of verification and control, taking

appropriate account of academic freedom.

The Commission has not perceived its task as being to expose specific damaging

effects. This will probably be a topic for a subsequent investigation by the Norwegian

Board of Health. Notwithstanding, the Commission has noted that colleagues,

researchers, clinicians and individual patients have probably used Sudbø's research

results, and it is therefore reasonable to assume that some of them have been affected.

The serious implications of this must have been obvious to Jon Sudbø right from the start.

1.5 The Commission's Report – an overview

appointment, the terms of reference and methods of working. The chapter discusses the

investigative principle adopted, mode of information retrieval, the principle of

contradiction, standards of proof, the relationship to disclosure, and thresholds for

criticism.

In Chapter 3, the Commission has found reason to outline the ethical and legal

framework that applies to medical and health research. Here, the Commission provides a

general review of the rules of authorship and supervision, etc.

Chapter 4 reviews the facts the Commission has chosen to take into account. The

facts are presented in chronological order, beginning with Jon Sudbø's PhD project,

which commenced in 1993. There is an explanation of the raw data underlying parts of

Jon Sudbø's doctorate and several subsequent publications. The Commission discusses in

detail which patient data Sudbø actually had or may have had, comparing it with the data

Sudbø and his co-authors stated that they have had in different publications. The

Commission then reviewed Sudbø's subsequent scientific publications, which are mainly

based on the original raw data from the PhD project.

In Chapter 5, the Commission has attempted to illuminate certain circumstances

that may help explain how and why things turned out the way they did.

Chapter 6 offers a brief discussion of the possible consequences of the situation,

not least for Norwegian research and patients.

Chapter 7 summarizes the findings and the circumstances worthy of criticism

which the Commission has found reason to point out. This criticism refers to individuals

and institutions alike.

Finally, the Commission has made certain recommendations in Chapter 8 by way

of conclusion.