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

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

2.1 Appointment of the investigation Commission

On Friday January 13, 2006, the Rikshospitalet-Radiumhospitalet Medical Centre (RR MC) and the University of Oslo informed media that a scientist employed there had admitted to fabrication of data underlying a scientific article in the renowned medical journal The Lancet.

On Wednesday January 18, 2006, the Rikshospitalet-Radiumhospitalet MC and the University of Oslo made it known that they would appoint a special Commission with detailed terms of reference (section 2.3) to perform the investigation and clarify the facts.

2.2 The Commission’s composition

The Commission was composed as follows:

  • Professor Anders Ekbom, M.D., (Chair), Institusjonen för medisin, Karolinska Universitets Sjukehuset, Stockholm

  • Special Advisor Gro E.M. Helgesen, Cand.Pharm., the Research Council of Norway

  • Post doc Tore Lunde, LLD, the Faculty of law, the University of Bergen

  • Researcher Aage Tverdal, Professor, PhD., the Norwegian Institute of Public Health

  • Professor Stein Emil Vollset, PhD, the Department of Public Health and Primary Health Care, the University of Bergen
    - - -

  • Research fellow Sigmund Simonsen (Secretary), Master of law (Norway), LL.M, the Department of Community Medicine and General Practice, the Norwegian University of Science and Technology.

In addition, the National Cancer Institute (NCI), USA, was offered a seat on the Commission, but has not accepted the invitation.

2.3 The Commission’s terms of reference

The purpose of the investigation is to identify and review all factual matters in connection with the research article ”Non-steroidal anti-inflammatory drugs and the risk of oral cancer: a nested case-control study” by J. Sudbø et al. in The Lancet, vol 333, pp. 1359-1366, October 15, 2005. The Commission shall also assess other research and other matters considered by the Commission to be related to this case.

The Commission shall make such investigations as it finds necessary to clarify the extent of the breach of standards of scientific research and other criticizable factors.

The Commission shall attempt to clarify whether there are special factors that have influenced what has been done in this case, including the researchers’ self interests as well as whether special external interests, frameworks, conditions and tying arrangements for the activity exist.

The Commission shall map and assess any harmful consequences of the research and of other factors included in the terms of reference. This applies to whether this has been harmful in connection with the treatment of patients and if so what harmful effects have ensued. The Commission shall also attempt to map and assess the negative effects caused to the scientific research at the Rikshospitalet-Radiumhospitalet MC and relevant areas of research at the University of Oslo as well as scientific research at other institutions.

The Commission shall assess rules and routines for control and quality assurance which apply to scientific research at the Rikshospitalet-Radiumhospitalet MC and the University of Oslo, and whether these have been complied with in this case. The Commission shall assess whether these rules and routines should be changed, and if so, submit proposals for such changes.

If the Commission during its work should become aware of factors that have effects which should be notified prior to the conclusion of the Commission’s work, the Commission must bring this to the attention of the appointing institutions as quickly as possible.

Should the Commission be of the opinion that the terms for reference are limiting the work, this must be brought up with the appointing institutions immediately.

The Commission shall submit its report to the Rikshospitalet-Radiumhospitalet MC and the University of Oslo no later that April 1, 2006, whereupon the report will be made public at the same time as being dealt with independently by the Boards of the two institutions.

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

      1. The Commission’s legal status

The investigation commission was appointed by the Rikshospitalet-Radiumhospitalet MC (RR MC) and the University of Oslo (UiO) (hereinafter the “Appointing Institutions”) which are, or have been, the employer of the researcher who has admitted to having fabricated research data, and who was the cause of the investigation. This means that the Appointing Institutions are two public institutions.

The Commission is not a “public investigation commission”, but rather a temporary and professionally independent administrative body of a special nature, comprised by unbiased experts, created by the management of the aforementioned two public institutions jointly for this case to perform an investigation on their behalf. A fundamental consideration for the Appointing Institutions as well as the Commission has been to have a professionally independent investigation.

There are no particular procedural rules laid down in statute or regulations for this type of ad hoc appointed commissions. In 1968, a committee appointed by the Government submitted a Recommendation for Rules for Investigation Commissions (printed in 1969). The Ministry of Justice then prepared a circular1 containing a mixture of information, instructions, guidelines, and provisions of a more mandatory nature2. The circular is aimed at public investigation commissions appointed by the Government or a ministry, so-called “public investigation commissions”. It is therefore obvious that these guidelines are neither prepared with this Commission in mind nor binding for it.

Since the Commission is a body for two public bodies, it is clear, however, that the Commission is subject to the Public Administration Act and general non-statutory requirements as to generally accepted administrative practice. Since the Commission’s report is not an individual decision in the terms of the Public Administration Act, only chapters II and III of the Public Administration Act have been of particular importance to the work.

      1. Impartiality and independence

In accordance with the provisions of section 8 of the Public Administration Act, the Commission has considered its own impartiality. No committee member is related to the parties to the case, and the Commission cannot see that circumstances exist that are apt to impair confidence in its impartiality, cf section 6 of the Public Administration Act.

The Commission has placed great emphasis on the consideration of independency in the contact between the Commission and the Appointing Institutions. The Appointing Institutions have made conditions favorable so that is has been possible to carry out the investigation independently, self-contained and without restrictions on the use of resources. Out of consideration for the Commission’s independency, its secretariat has not been physically or functionally localized together with the Appointing Institutions, persons or institutions that could have become the subject of investigation. Thus the Commission has made use of premises for the secretariat in Trondheim, and most of the meetings have been held in meeting rooms at Gardermoen [Oslo Airport] in addition to telephone meetings. One meeting was held at the Radiumhospitalet in connection with an inspection and talks with employees, and one meeting was held at the Cancer Registry. The Commission has had good framework conditions for carrying out the investigation.

      1. Legal measures

The Commission is not authorized to make searches or seizures. People to be interviewed were not under a duty to give any statement to the Commission. The legal basis for obtaining evidence, in the form of oral and written information, including emails and interviews, is consent. All the persons the Commission wanted to interview consented in providing information to the Commission. The same applies to other persons and institutions to which the Commission has addressed inquiries and questions. In general, persons and institutions concerned have collaborated well with the Commission. Nobody refused to collaborate with the Commission.
      1. The duty to clarify the case principle and the sound procedure principle

The Commission has observed the duty to clarify the case principle in section 17 of the Public Administration Act and the principles inherent in requirements as to sound procedure and generally accepted administrative practice. Within the limited time frame available, the Commission has sought to obtain the widest possible information basis, which has included making critical checks of information received from various sources and comparing these against each other with the aim of discovering any discrepancies.

However, the Commission points to the difficulties caused by the fact that some of the circumstances subject to investigation occurred more than ten years ago. Such a comparatively long time span obviously influences the interviewed persons’ possibilities to recall details of what took place. The reservations which for these reasons have been necessary to make in relation to what can be deducted from the evidential material, have nevertheless not altered the Commission’s main conclusions, as these are stated in the report.

      1. Contradiction

In order to ensure a reliable procedure in line with fundamental considerations of the due process of law and requirements as to generally accepted administrative practice, the Commission has taken as its point of departure, and practiced, the guiding norms laid down in the circular as far as serviceable and natural. The individuals who have been investigated have been notified of this and they have been urged to contribute voluntarily. At the same time, they were informed that they might be subject to criticism and that they in such a case would be notified especially if this would be the case. The individuals who are subject to criticism have also been allowed to read memos, documents and finally the draft report itself, i.e. Chapter 4 through Chapter 7 (Chapters 1 through 3 and 8 contain more general considerations). Thus they have been given the opportunity to respond to the criticism and make contributions at several occasions. The Commission has also met with these persons.

The Commission will here note that the most central person in the investigation, Jon Sudbø, was assisted by his lawyer during the investigation. The procedure and factual matters have been discussed with Sudbø and his lawyer throughout. No substantial objections to the Commission’s outlined plan for the investigation as such have been made. In this context the Commission notes that Sudbø’s office material has been locked away by his employer during the entire investigation and that Sudbø has been given several offers of access to this material in order to extract documentation and the like of importance to this case. Sudbø has been sent two draft reports together with data lists, connections and other key documents on which the Commission has based itself. Sudbø submitted detailed comments to the first draft – which the Commission incorporated, but did not want to comment on the next draft he received.

In other words, the Commission has arranged for contradiction to a larger extent than it was obligated to do. This was done in consideration of individuals affected, but also in order to illuminate the case as well as possible.

      1. Requirements of proof and thresholds for criticism

The Commission’s primary task is to clarify the facts with the aim of discovering whether and to what extent breaches of standards for scientific research and other blameworthy acts have occurred. Like in legal procedures – both civil procedure and criminal procedure – also in investigation procedures there will be different degrees of proof for establishing facts as probable. The Commission has considered what degree of proof should be required in a case of this nature in order for the Commission to rely on particular facts as a basis for criticism.

In the Commission’s opinion there are several reasons why a more stringent degree of proof should apply than the traditional principle in civil procedure of proof by a so-called simple preponderance of probability3. In the first place reference is made to the fact that the object of the investigation is to clarify facts with the intention of discovering the extent of scientific dishonesty and the like. Criticism on such a basis must be considered highly invasive for the individuals involved. Taking into account the serious legal consequences and any sanctions that may be triggered by conclusions that scientific dishonesty, breach of generally accepted research practice and similar criteria exists, the ordinary principle of proof by a preponderance of probability must be deviated from in favor of the person concerned by the investigation. In the second place, in an investigation process the production of evidence and practice of the principle of immediacy will be more limited than during an ordinary court procedure. On the other hand, the Commission finds that there is no basis for requiring a degree of proof that is as strict as in criminal law. Based on an overall assessment, the Commission finds that the degree of proof to be applied in order for it to rely on a particular fact as proven should be proof by a so-called qualified preponderance of probability. The Commission has applied this principle in its investigation and preparation of the report.

The Commission has therefore, mainly out of regard for the due process of law, but also for pragmatic reasons, applied a very high threshold for criticism of persons. Many individuals have been involved in the research which has been subject to investigation, and, in the Commission’s view, any criticism for less serious acts may have a disproportionate effect on individuals, especially seen in the light of the Appointing Institutions’ express intention to publish the report as well as the extensive press coverage this case has been the subject of.

In relation to the institutions involved, however, the Commission has found grounds for a somewhat different approach. The Commission has notified two institutions that they might be subject to criticism. These institutions have been given the opportunity to read the criticism itself, but not the draft report in its entirety, and have thus been given a limited possibility to contribute. Furthermore, the Commission has chosen not to notify the Appointing Institutions: the Rikshospitalet-Radiumhospitalet MC and the University of Oslo, although these as responsible institutions must suffer criticism. Notification has been omitted to prevent the risk of any unfortunate influence from these institutions. However, the Commission has had meetings with managers at several levels at the Rikshospitalet-Radiumhospitalet MC and the University of Oslo in order to clarify factual matters. The omitted notification and possibility to read the draft report are also related to the institutions’ relative strength compared to individuals. The consideration for the Commission’s integrity and professional independency has also been an important element in this assessment. The Commission has considered it such that the institutions to a completely different degree than individuals must put up with public criticism.

2.4.7 The presumption of innocence

The so-called presumption of innocence embodied in the European Convention on Human Rights (EHRC) Article 6 (2) states that “everyone charged with a criminal offence shall be presumed innocent until proved guilty according to law”. The Convention has been incorporated into Norwegian law, cf the Human Rights Act. The Commission’s terms of reference have been established with the aim of clarifying factual matters particularly related to the Lancet article, and discovering the extent of breach of standards for scientific practice. The formulation of the terms of reference implies that the Commission may perform its tasks without making findings of guilt that violate the presumption of innocence.
      1. Publicity

The Commission is an administrative body in the terms of section 1 of the Freedom of Information Act. The Freedom of Information Act thus applies to the Commission’s work. All documents

supplied to the Commission are subject to disclosure unless the grounds for exemption in sections 4, 5, 5a or 6 apply. Recording of statements, draft reports and similar notes are considered internal documents which may be exempted pursuant to section 5. This also applies to contributions and support documents supplied to the Commission by persons who have given statements, as well as in-depth comments they have given to print-outs sent them for perusal. Voluntary public access has not been given to statements recorded during the investigation. The Commission has received one request for access to documents, by Verdens Gang [a major Norwegian daily newspaper]. The request was refused pursuant to section 4 (1) of the Freedom of Information Act. Following a complaint from Verdens Gang and a renewed assessment, certain documents were released.

When preparing the report, the Commission has had in mind the Appointing Institutions’ express aim to make the report available to the public. Annexes that document errors and defects in the patient material and that contain patient identifiable information (in the form of block numbers, for example) have been exempted from disclosure and have only been submitted to the Appointing Institutions and the persons and institutions against which the criticism has been directed and which in that capacity previously have been dealing with these data. An anonymized and simplified version of these annexes, without patient­ identifiable information, has been included as an annex to the report which will be published.

The Commission will be dissolved after the submission of the report to the Rikshospitalet-Radiumhospitalet MC and the University of Oslo, and the documents in the case will then be handed over to and managed by the Rikshospitalet-Radiumhospitalet MC and the University of Oslo for filing in the normal manner. The material will be subject to the Freedom of Information Act and the legislation on archives. Any subsequent right of access may, moreover, be limited due to restrictions which may follow from consents given, secrecy rules and the like.

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