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

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3. Regulation of medical research

3.1 Overview of the applicable set of rules

The second section of the terms of reference reads:
“The Commission is to make such investigations as it finds necessary to clarify the extent of breaches of standards for scientific research and other blameworthy matters.”
“Breaches of standards for scientific research and other blameworthy matters” is a very broad concept. The concept aims at acts and omissions which are in breach of established norms of operation/rules of operation – here: good research practice. Such norms or rules for accepted conduct may have different status and designation, as for example:

  • Ethical norms and social norms5

  • Vocational norms (researchers and medical staff’s self regulations)6

  • Instructions and norms laid down by the employer

  • Legal norms (statutory and non-statutory legal rules)7

The regulation of medical and health related research is marked by an intimate interaction between ethics, law and the profession’s own norms, where the ethics (ethical reflections) normally forms the basis for legal norms as well as the profession’s own norms.

The Commission will not here give a detailed description of all relevant rules that apply to medical research. These rules have recently been described comprehensively in other presentations, and the Commission would refer to these.8

However, the Commission will very briefly outline the existing legal framework against which this specific case has been assessed. The framework defines the expectations and requirements made to Norwegian researchers and research environments.

Although, basically, research is to be free and independent, there are of course rules of the game which researchers must follow in the same manner as everybody else.

There are a series of rules and control routines for medical and health related research. Traditionally, the research community has regulated itself, via the development of norms for good scientific practice (professional norms and sector practice). In later years however, the legislative authorities have also played a more active role, particularly as regards medical and health related research that involves people, human biological material and/or personal data.

The Patients’ Rights Act, the Biobanks Act and the Personal Data Act are key examples of statutory legal rules. Non-statutory legal rules come in addition. A series of written and unwritten professional norms (self regulations), as for example the Helsinki declaration prepared by the World Medical Association (WMA) and the so-called Vancouver rules, cf section 3.5, are moreover still highly relevant. More detailed working instructions or implied requirements as to acceptable conduct at the individual research institutions come in addition. These are currently available at the institutions’ intranet. An increasing amount of international directives and conventions are also influencing the regulation of medical and health related research, and contributes, i.a., to many similarities between the national regulations in various countries. The EU Personal Data Directive 1995 and the Medicine Directive 2001, as well as the European Council’s Convention on Biomedicine and Human Rights 1997, are examples of the latter.

A public committee which reported on the regulation of medical research, the Nylenna Committee, found that a lack of regulations was not the primary problem, although certain flaws existed.9 In the committee’s view, the main problem was that the regulations were fragmented, complex and inaccessible, and that very few people for that reason seemed to have satisfactory overview of the set of rules.

In order to obtain an overview of the current set of rules for research, it may be appropriate to differentiate between various types of norms of operation for medical and health related research, based on the purpose of the norms (although these obviously must be seen in connection):

  • Protective rules: These concern rules aiming at protecting the integrity of the individual person (research participant).
    The main rules are that consent by the individual research participant (i.e. the person participating in the research directly or indirectly, i.a. by giving tissue samples or personal data) must exist. In addition, the research must be sound and in line with good research practice, as well as be assessed in advance by one of the regional committees for Medical Research Ethics (REK) and other relevant bodies.
    The regulations do not only comprise research on humans, but also the use of exclusively human biological material and personal data. Violation of these rules will often be considered as serious,

because they jeopardize other people’s life and health, or infringe their integrity (private life). These regulations are therefore often a result of statutory provisions or non-statutory law.10

The Human Rights Act 1999, the Medical Personnel Act 1999, the Patients’ Rights Act 1999, the Specialist Health Services Act 1999, the Biobanks Act 2001, the Personal Data Act 2000 and the Personal Health Data Filing System Act 2001 are key statutes in this field. The so-called Helsinki Declaration 196411 indicates principal professional norms. The legislation relating to the protection of animals comes in addition in the case of experiments on animals.

  • Rules for scientific integrity: This concerns rules aiming at regulating the research itself, as for example norms for the choice of method, design of studies and the like, which are to ensure that research results are valid and that the knowledge can be generalized. It is therefore fundamental that data should not be manipulated, fabricated or falsified. Furthermore, the inclusion of research participants must not be unduly selective, and research data must be stored for some time after completion in order to secure the opportunity to check. Honesty, thoroughness, completeness and openness are key ideals here.12
    Violation of one or several of such norms of conduct/rules (good scientific practice) may entail that the research results cannot be considered as valid.
    These rules are primarily unwritten and follow from established scientific practice and good research practice as well as more general requirements to soundness.

  • Publication rules (integrity rules): A third group of regulations are those applying to the publication of research results. This concerns rules that are to contribute to openness around and opportunity to check research results, i.e. that what is written in the publication is in fact correct and adequate, such that others can use it as a basis for their further work. That which speaks for and against (positive as well as negative) results must be stated. Conflicts of interest, associations and the like which can be imagined to have influenced the results, should also be stated. Another dimension,

which can also be said to belong in this “group of rules”, is rules and practice concerning authorship, plagiarism and copyright.13

These rules also primarily follow from established scientific practice and good research practice, as well as more general requirements as to soundness. The Copyright Act 1961 and the so-called Vancouver rules may also be relevant in this context.

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