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

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3.2 Different degrees of norm deviation, guilt and blameworthiness

It is important to emphasize that deviations from norms and breach of rules occur in many shades – from the trivial to the conspicuous.14

In the recently enacted Research Ethics Act (not yet in force) section 5 (2), the so-called scientific dishonesty is restricted to certain gross and serious deviations, i.e. “falsification, fabrication, plagiarism and other serious breaches of good scientific practice perpetrated with intent or gross negligence”.

Obviously also “less serious” deviations occur, which may nevertheless represent a breach of good research practice, as for example flawed source references, failing design, breach of quality assurance routines, misleading authorship, or by “disregarding” extreme or unexpected observations and other oddnesses which do not entirely agree with one’s own hypotheses. Such deviations must also be taken seriously, since they are suited to impair the quality and trustworthiness of the research, and to create a climate for more serious deviations.

Thus there is a sliding transition from the trivial to the gross and more serious deviations.

In the same way, the degree of guilt will vary, from excusable mistakes via cases in which one has acted unintentionally but nevertheless should have acted differently (negligence), to willful breach of the rules, knowingly committed. Norm deviations may thus be criticizable and blameworthy even if the researcher has not acted knowingly, but maybe rather been negligent, uninterested, careless, incompetent or the like.

The degree of blameworthiness will thus depend on the degree of the norm deviation and guilt.

3.3 Personal liability and overall system responsibility

The main rule in Norwegian law is that an individual is liable for his/her acts and omissions. Thus the individual person may be held personally liable for what he/she has done, alternatively not done, but ought to have done, and be met by different sanctions. This follows from general principles of non-statutory negligence liability and more special liability rules, among other things.

The large majority of researchers, however, are ordinary employees in public or private sector. This means that in addition, it may be question of a system liability for the employee’s superior, i.e. the person/organisation who is liable for the person who actually performs the act. Personal liability does not exclude system liability, and vice versa.

Basically, employers are liable for the acts of their researchers, and the main rule is that they are liable for the acts of their employees, irrespective of whether the employer is to blame or not. This so-called employer liability follows from section 2-1 of the Act relating to Compensation for Claims, of which subsection 1, first sentence, reads:
An employer is liable for damage caused willfully or negligently during the employee’s performance of work or assignments for the employer, taking into account whether the expectations the parties sustaining the loss reasonably can make to the activity or service have been neglected.
For example, research is stated as one of the main tasks of the specialist health service on the same level as medical treatment, cf section 3-8 no 3 of the Specialist Health Services Act. The requirements in the Specialist Health Services Act relating to soundness, organization and management at different levels will thus apply to research. The medical centers have a hierarchic system, with the state as owner, having in principle the superior responsibility as well as the managerial prerogative and right to instruct, cf sections 3 and 7 of the Health Enterprises Act.15 However, the state has appointed a board of directors, which again has appointed a general manager, a CEO, having the day-to-day responsibility and managerial prerogative and right to instruct, cf section 37 of the Health Enterprises Act. But this responsibility, including the managerial prerogative and right to instruct, will be delegated downwards and distributed to clinical managers, department managers, sections heads and project managers (including project managers for research projects, i.e. the person having the day-to-day responsibility for a specific research project).16 Section 3-9 of the Specialist Health Services Act states that there shall be a responsible manager at each level. But such hierarchic delegation (line management) does not mean that the superior person in the line ceases to be liable. In principle, nothing prevents the overall liability to be divided, for example between a medical centre and a university. In such cases, however, it will normally be a question of joint and several liability, i.e. that both institutions are liable irrespective of each other – one for all, all for one. In general it must be assumed that the institution to which the day-to-day research has its closest relation, typically the hospital, carries the primary responsibility for the research.

Preparation and sound organization of the research, stating responsibilities and such like, are thus key tasks for the employer, i.e. the research institution. Where research is concerned, proper account must of course be taken of the customary academic freedom, i.e. that the employer must not in any undue manner try to influence the research. The employer may nevertheless not provide employed researchers with unlimited authority and disclaim any liability. Thus the employer may also be held liable on an independent basis, for example due to lack of routines, training, management, control and supervision in connection with research as well as medical treatment. This applies in particular when patients, patient material, patient data, animals or other sensitive research objects are involved in the research.

The current Act relating to Universities and Colleges of April 1, 2005, states explicitly in section 1-5 that universities and colleges may not be instructed regarding the academic contents of their teaching and the content of research or artistic or scientific development work. In evaluations of Norwegian research a stronger professional management is at the same time called for. Professional management and management structures may establish frameworks for research to be performed by the individual employed scientist. Tension may therefore exist between the individual person’s academic freedom and the institution’s professional management responsibility at all levels, even if the act does not contain provisions that directly can be said to restrict the individual academic freedom in an unfortunate way.

The recommendation, Innst.O. nr 70 (2005-2006), from the parliamentary standing committee on church, education and research concerning the Act on Research Ethics, states:

The committee takes as its point of departure, as did the Government, that research takes place under a considerable degree of freedom and trust, and thereby also a considerable degree of personal responsibility for the individual researcher. At the same time, there is reason to underline that the research institutions have an independent responsibility for control and management. However, the institution’s professional management responsibility must continuously be assessed against the concern for academic freedom and the individual scientific employee’s rights. The committee has noted that this issue will be discussed by the so-called Underdal committee, which is to submit its recommendation in October 2006.
It should be noted here that employed researchers, in spite of these formal points of departure, traditionally have had an extremely free role at most of the public research institutions, among other things indeed to secure the professional independency of research. However, it should be noted that there is not necessarily a contrariety between professional integrity and independency, and an overall responsibility for and supervision of the institution’s activity being sound.
A need to raise awareness of the research institutions’ responsibilities and duties is a common subject in reports on the regulation of medical and health research.17

Supervisors in PhD or master degree projects may have different roles, and do not necessarily form part of research institutions’ line management. In clinical research, the supervisor will often also be a co-researcher, and then usually a project manager, so that this person holds the day-to-day responsibility for the specific research project. The supervisor will then have an overall line responsibility for the PhD candidate or the student. But the supervisor may also have a more retired role by functioning solely as an advisor and conversation partner (mentor). In such cases, the supervisor’s responsibility will be more modest and derivative. The role as supervisor is discussed in more detail in section 3.7.

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