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

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2.5 The Commission’s relation to the terms of reference

The terms of reference are stipulated very broadly. The formulation of the terms of reference must be seen in the light of the fact that the Appointing Institutions at the time of appointment obviously did not have a full view of the more detailed nature of the case and its extent, and that one did not want to place restrictions on the Commission’s investigation.

Furthermore, the Commission has noted the extensive press coverage and debate which followed in the wake of this case, including more or less explicit expectations to the Commission held by commentators and others. Obviously, the Commission has neither tried nor had any possibility to accommodate all such expectations.

However, in line with its terms of reference, the Commission started out broadly and considered a series of relevant factors. At the same time it was evident that it would have been an insurmountable task to make an equally thorough assessment of all the questions raised in the terms of reference within the limited time frame at the Commission’s disposal. The Commission has therefore had to make continuous delimitations and definitions of the terms of reference. The Commission has then had to prioritize those factors that in the Commission’s view have appeared as the most central and serious.

In the terms of reference the Commission was asked to submit its report to the Appointing Institutions no later than April 1, 2006. The Commission gradually saw that it would not be possible to comply with this deadline. A new deadline was fixed at June 30, 2006 according to the Commission’s own suggestion.

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

      1. In general

The members of the Commission have performed their assignment in addition to other tasks. The Commission’s secretary has worked full time for the Commission and also had a 20% position at the NTNU. Furthermore, the Commission has received assistance with office work, i.a. for transcription of interviews, from Marit Kvidal and Toril Synnøve Strand. All have signed a statement on confidentiality.
      1. Meeting activity

The Commission has held 13 all day meetings and 11 telephone meetings. A fair amount of the meeting time has been spent to meet key persons – altogether 15.
      1. Retrieval of information

The Commission’s principal task has been to clarify the facts. The Commission has obtained written as well as oral information. The scope of information is considerable. The written material is stated in document lists included as annexes to the report. The material can be grouped into 1) research publications in which Jon Sudbø was the first author or coauthor, 2) correspondence, including email between the Commission and persons, institutions and public authorities involved, and 3) data files containing information on background material used, including data files prepared by the Commission with the aim of reconstructing and checking the background material. All information has partly been recorded on tape and then transcribed, partly received per telephone and recorded in internal case documents and/or exchanged per email to the members of the Commission, and partly received in meetings, without tape recordings having been made, but where information has been recorded in internal case documents. The Commission has used information relevant to the terms of reference only.

It is inherent in the terms of reference that it is research under the auspices of Jon Sudbø that has been at the centre of the work, because Jon Sudbø, based on the information existing as per the time of the

appointment, already had admitted to fabricating research data as regards an article in The Lancet from October 2005.

Consequently, the Commission decided early on, in view of the nature of the case, that the entire scientific activity and production by Jon Sudbø, which according to the data base PubMed4 comprise 38 publications, had to be investigated, see the publication list, Annex 1. A more detailed account of this is given in the review of the facts in Chapter 4.

This meant that the authors who had contributed to publications together with Jon Sudbø (approximately 60) in fact also have been subject to investigation. These persons have been treated equally. The authors were notified in writing that formally they were subject to investigation, and formally notified that this could result in criticism. At the same time, they were asked to make a written statement voluntarily. They were also informed that they were under no duty to give such a statement, since the Commission had no authority to order statements from anyone. The authors all responded to the Commission’s request. In addition, certain persons and collaborators who are thanked in Acknowledgements were contacted. The Commission has also asked additional and follow-up questions as needed. Several authors and collaborators have also given oral statements before the Commission (15 persons). Jon Sudbø has made oral and written statements to the Commission. With the understanding of the persons interviewed, most of the statements have been recorded on tape and transcribed. Those who have given statements have been given the opportunity to read the transcripts from the conversations, and submit corrections, definitions or additional comments. In accordance with the conditions for tape recording stipulated by the interviewed persons themselves, the tapes have been deleted by the Commission.

The Commission has also obtained written and oral information from relevant bodies and institutions with which Jon Sudbø has been in contact in connection with his research. Particular mention should be made of the Cancer Registry of Norway, which itself has performed very extensive investigations as part of its own internal control, i.a. because the Cancer Registry allegedly has been a key cooperation partner for Jon Sudbø. The Cancer Registry’s independent investigations have been of great value to the Commission, first and foremost because the Cancer Registry has access to most of the background data used by Sudbø in his research.

As accounted for in detail in Chapter 4, the key information carrier has been available data lists and published research results which could illuminate the background material which forms the basis for Jon Sudbø’s research. These data files have then been correlated and compared with each other and other available documentation, i.a. from the Cancer Registry. In this way, the Commission has tried to

recreate the actual background material which has or with a high degree of probability has been used by Jon Sudbø in his research.

      1. Good scientific practice, norm deviation and dishonesty

As already stated, one object of the investigation has been, through a clarification of the facts, to discover whether any breach of good scientific practice, i.e. breach of good research practice, has occurred. The Commission has subsequently delimited this object to apply to gross and serious breaches. This means first and foremost “scientific dishonesty”, as this has been defined traditionally, as well as more serious degrees of negligence and blameworthiness. The criterion “scientific dishonesty” has recently been enacted in the Act on Research Ethics (not yet in force) in which section 5 (2) reads:
“Scientific dishonesty means falsification, fabrication, plagiarism and other serious breaches of good scientific practice perpetrated with intent or gross negligence in the planning, implementation or reporting of research.”
In view of the fact that the requirement of guilt for scientific dishonesty is formulated as a requirement of intent or gross negligence, the Commission has applied a relatively high threshold for finding breaches of scientific honesty, as well as gross and serious breaches of good research practice. The Commission also refers to section 3.2. On this basis, the Commission has not considered it appropriate to make a detailed investigation of each one of the 60 authors, with the aim to discover deviation from norms which must be considered to be of less importance in relation to the main issue in this case.

This important delimitation is first and foremost justified by the fact that such less serious cases are in an entirely different category from the serious allegations which it has been the Commission’s primary task to investigate. It should be underlined that this must not in any way be construed as an attempt by the Commission to play down petty offences. On the contrary, the prevention of any form of norm deviation from good research practice has been given great emphasis in the Commission’s recommendations. The delimitation must rather be seen in light of a real and everyday need to establish a practicable framework for the Commission’s work. Within the Commission’s restricted time frame it has not been possible to investigate each individual author in detail, with the requirements as to thoroughness and due process this would have entailed. The Commission here refers to the fact that each individual person who the Commission might have found reason to criticize directly, regardless of whether trivial or serious acts were involved, would have had to be given the opportunity to give a statement and refute any criticism directed at him/her (the contradiction principle). Finally, the Commission emphasises that the work connected to

discovering the most grave and serious acts has been much more extensive than what one had reason to predict in the beginning.

On the other hand, the Commission has found reason to present certain more general remarks related to how researchers and research institutions should act, including the lesser norm deviations which seem to have occurred. Thus, the criticism of persons is first and foremost related to gross and serious norm deviations, whereas the detection of less serious matters has been restricted to a more general and institutional level.

Accordingly, two questions have been at the centre of the Commission’s clarification of the facts:

  1. Have gross and serious breaches of good research practice taken place, and if so, to what extent?

  2. What happened (causal factors), and who is responsible for any breaches of good research practice?

Before replying to these questions, the Commission has found reason to outline the general framework and the background against which this specific case has been assessed, see Chapter 3.

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