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

Flaws in sets of regulations and similar formal types of control

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

The serious breaches of good scientific practice discovered in this case, are in all essentials breaches of fundamental and unambiguous rules which have existed for a long time. The prohibition against improper manipulation and fabrication of research data is embedded in rules that all researchers must be assumed to be well acquainted with. Therefore, the Commission cannot see that the facts discovered are due to a lack of rules.

On the other hand, the Commission has discovered a series of minor breaches, which in aggregate have contributed to a system in which the breaches of good scientific practice have been allowed to increase without being discovered earlier. But also here it seems, in the Commission’s opinion, not to be the lack of rules which is the problem, but rather the individual researcher’s and institution’s knowledge and practicing of the rules which actually exist. The Commission would here as an example refer to the fact that the PhD project should have been submitted to the Regional Committee for Medical Research Ethics, the Data Inspectorate and the Norwegian Board of Health (now: The Directorate for Health and Social Affairs) and that these are factors no one has reacted to, neither coauthors, supervisor(s) or the management of the institution, nor those who were responsible for approving the PhD degree.

The Commission’s findings on this point are in harmony with three studies related to the regulation of medical research:

In its concluding report from 2001, the then National Committee for the Evaluation of Dishonesty in Health Research stated that it was important to have clear rules for good scientific practice. One therefore prepared a guide to the implementation of projects in medical and health research. The committee was concerned that such thematic should form part of the mandatory part of the research education, but believed

that it was just as important that an environment for lifelong learning within research ethics and good research practice should be developed. The committee underlined that the responsibility must lie with education institutions and research environments themselves, but that a central initiative to initiate the process was needed.

This is moreover in harmony with the Nylenna Committee’s report from 2005 on the regulation of medical and health research.46 The Nylenna Committee found that it was not primarily the lack of rules that was the problem, although certain deficiencies existed. The main problem was in the committee’s opinion that the rules were fragmented, complex and inaccessible, and that few people had an overview of the set of rules. Simplification and clarification of the set of rules and bureaucracy, as well as making the research institutions more clearly accountable, was the Nylenna Committee’s main recommendation for measures.

This approach was also given weight in the preparatory works to the Research Ethics Act.

Thus, the Commission’s opinion is that the facts discovered are not primarily related to a lack of rules, but rather that there has been a lack of measures to prevent breaches of good scientific practice through the implementation of simple and effective routines. The latter is first and foremost an institutional responsibility. The Commission has in fact noticed that over the last years there has been an increasing awareness of these factors at several research institutions, among others at the Rikshospitalet/Radiumhospitalet MC, which has implemented a series of measures to guide researchers.47

6. Possible consequences

6.1 Reflections on consequences for research

The fabrication of research data is counted among the most serious forms of dishonesty in research. When such things occur, it contributes to a general weakening of the society’s trust in research. For medical and health research, this doubt about trust may also have consequences for the trust in the health services in more general terms. Such doubt may create insecurity and concern in the population. The researcher community is highly dependant on society’s trust, both to ensure that there is a political will to use public budgets to fund research, and that the population will be willing to participate in various research projects.

The Nordic countries have traditionally had a positive reputation within clinical as well as epidemiological research. Based on these countries’ health and disease registers, and the possibility of linking data to comprehensive population registers with unambiguous identification opportunities, the Nordic countries traditionally have been sought after as collaboration partners in research projects. For small countries, this type of research collaboration is often of crucial importance for being able to participate in the front of international research. The discovery of dishonesty linked to the use of such registers may weaken the global research communities’ interest in collaborating with Nordic researchers.

Research is by nature truth seeking and critical, and has an important task in questioning “established” truths. It is also incumbent on the researcher community to ensure that research activities take place within ethical and honest norms at all times. When dishonest conduct is discovered, the increased focus on norms and the practice of professional ethics provides an opportunity for a renewed discussion of the following up at all levels of research. This case becomes an “eye-opener” which may contribute to an enhanced concentration on the prevention of dishonesty. Even if rules and guidelines for ethical and honest research conduct exist, there is a need for continuous focus on these questions, not least in the researcher education.

The Commission has difficulties in having clear conceptions of whether this case specifically will harm the reputation of Rikshospitalet/Radiumhospitalet MC and the University of Oslo, but the names of these institutions, in particular the first mentioned, will inevitably be linked to Jon Sudbø. It will probably be necessary to allocate resources to show increased openness relating to the practicing of guidelines and quality assurance routines in order to restore and maintain trust. An effort to explain away what has happened will easily be contra productive as regards regaining the trust of the population and authorities. Most people understand and accept that errors and failures can occur now and then.

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