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



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3.4 The application of the rules in time

A basic principle of the due process of law is that the rules prevailing at the time when the act of omission occurred shall apply.

Because circumstances in this specific case span a period from 1993 to 2006, it has been important to the Commission to clarify the rules in force at all times.

As a point of departure, one may say that the current main principles, as presented above, have been unchanged since 1993 when John Sudbø started his PhD project and his scientific career. Scientific dishonesty was, in other words, as unacceptable then as now.

In this connection, the Commission has obtained statements from the Regional Committee for Medical Research Ethics-South, the Data Inspectorate, the Norwegian Social Science Data Services and the Directorate for Health and Social Affairs. These bodies clearly state that the current rules in the areas that have been relevant in this case in all essentials correspond to the rules and principles existing and being practiced in 1993. As an example, the requirements as to a licence for, and an advance assessment of, research projects by the Data Inspectorate and the Regional Committee for Medical Research Ethics respectively applied then as now. The same was true for the requirement for either a participant consent or dispensation from the duties of secrecy by the Directorate for Health and Social Affairs for the use of patient information in research subject to a duty of secrecy. Earlier, prior to January 1, 2002, this public authority task was vested in the Norwegian Board of Health.

On the other hand, a certain tightening of the rules at the more detailed level, as for example the rules on the protection of personal data, has taken place. The most important is perhaps an increasingly raised awareness surrounding the rules that apply among researchers, institutions and public bodies.

The employees at the Rikshospitalet-Radiumhospitalet MC and the University of Oslo have also been given increasingly more and more defined internal rules and instructions to relate to at the work place than they had previously.

3.5 In particular about authorship

3.5.1 Some points of departure


The Commission sees the need for an introductory presentation of rules and practices related to issues linked to authorship on a more general level before commenting on individual circumstances.

Under this section, the Commission will first refer to the fact that the discussion on authorship, coauthorship and contributors within medical research is an old and continuously recurrent subject matter that has been the object of extensive discussions internationally for years. The question of who is the legitimate author of an article is one of the most discussed and controversial questions within medical publishing.18

Several arguments may be pleaded in favor of uniform rules for authorship.

In the first place the responsibility to readers including the scientific community presupposes that the person or persons stated as authors in fact can defend the message presented.

In the second place various requirements to and different practicing of rules relating to authorship may give an incorrect and unjust basis for comparisons within the system of merit in which scientific authorship plays the lead. One aspect in this connection is also funding systems within scientific research,

where authorship is one criterion in relation to the granting of research support. In later years, the financial incentives related to such authorship have been reinforced by governments.



      1. The Vancouver rules for medical publication


The so-called Vancouver rules or criteria19 are at the centre of the discussion on authorship within medical and health research. These standardized criteria were prepared under the auspices of a small group of editors of international medical journals, who met informally in Vancouver in 1978, with the aim of establishing guidelines for manuscripts delivered to the publications. The group, gradually becoming known as the Vancouver Group, published the guidelines initially in 1979. The Vancouver Group expanded and gradually developed into the International Committee of Medical Journal Editors (ICMJE) meeting annually. The criteria have been subject to continuous revisions. The Vancouver Group has been a small group without any real formal or legal status. In spite of this, the Vancouver Group has worked up an authoritative status enjoying the respect of researchers, academic institutions and public authorities globally. The authoritative force of the Vancouver rules can to a large degree be ascribed to the important medical journals represented in the Group, among them the American New England Journal of Medicine and Journal of the American Medical Association (JAMA), as well as the British Medical Journal (BMJ) and The Lancet.

The fundamental idea behind the Vancouver Group’s criteria for authorship is that authorship is an intellectual activity and that the ideas, analyses and not least the preparation of manuscript itself are the core of the scientific authorship.20

This idea is in good harmony with the more general criteria for authorship and general copyright principles. It should be noted, however, that the Vancouver rules are not more stringent than more general criteria. On the contrary, the Vancouver rules have been subject to continuous adaptations which make them currently appear as relatively liberal, in the sense that for example data retrieval is now equal to idea/design and analysis/interpretation. By the revisions of the last 10 years, the Vancouver rules have also downgraded the responsibility to be borne by the individual author, see Annex 2. Whereas in 1997 they stated that “Each author should have participated sufficiently in the work to take public responsibility for the content”, later versions state that “Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content”. The 2003 version stated that “one or more authors shall take responsibility for the integrity of the work as a whole, from inception to published article”. In the 2006

version this responsibility is further weakened to “Some journals now also request that one of more authors, referred to as “guarantors”, be identified as the persons who take responsibility for the integrity of the work as a whole, from inception to published article, and publish that information”.

Thus the Vancouver rules may be considered as a definition of the more general authorship principles which apply generally in all fields. In other words, the criteria are adapted to the particular circumstances one believes exist in relation to medical research and publication of medical research results in medical journals. The authorship criteria are thereby not necessarily characteristic of the principles applying outside the medical professional area. In this context, the Commission in particular notes the new amendments of 2000 following a critical revision, in which to collect data was assigned a value, which together with writing and approving the manuscript may lead to authorship. The fact that supplying data material may qualify for authorship is, in the Commission’s view, related to this being widespread in the medical professional community, and that it is often a precondition for being able to perform medical and health research. To a large degree one is dependent on sub-suppliers who do not necessarily participate in the intellectual process of the research project and/or the publication of the research results but who nevertheless have a substantial role in the research project. They are necessary contributors for the research project being able to be implemented. This contribution and the expertise held by the sub-suppliers must in one way or another be rendered visible and valued. These factors, in combination with medical publications also having become an important element in the medical community, have resulted in a practice in which persons are credited for their efforts in the research projects through a coauthorship, without having necessarily contributed to any particular degree to the intellectual process and creation of the intellectual work itself which one associates with authorship in general. In many important medical studies it is not unusual that an article has from 20-50 coauthors. The typical contribution, which is in full compliance with the Vancouver rules, can then be contributions with patient or other data material as well as a critical review of a final manuscript and its approval. For many people, and then in particular the general public, it may appear as rather incomprehensible that one departs from the general perception of the authorship concept.

The authorship criteria stated in the Vancouver rules must be seen in light of medical research often being characterized by collaboration projects. One is often collaborating across professional areas, for example laboratories and statisticians collaborating with clinicians and epidemiologists. Cooperation also takes place across institutions, and not least across national borders. This leads to a split of areas of work and responsibility. These factors have been at the centre of the debate linked to coauthorship.


But such distribution of tasks may also contribute to pulverizing the responsibility. The Vancouver rules have taken this into consideration in that publication under the auspices of large research groups shall include one or several authors/coauthors assuming the primary responsibility for the publication and the project as a whole, in the same way as the project manager will have the primary responsibility for the planning, implementation and completion of the research project as a whole.

For the sake of completeness, the Commission finds is appropriate to include the key provisions in the Vancouver rules in their entirety, as they read per June 1, 2006:

“II. Ethical Considerations in the Conduct and Reporting of Research

II.A Authorship and Contributorship



II.A.1. Byline Authors

An “author” is generally considered to be someone who has made substantive

intellectual contributions to a published study, and biomedical authorship

continues to have important academic, social, and financial implications. (1) In

the past, readers were rarely provided with information about contributions to

studies from those listed as authors and in acknowledgments. (2) Some journals

now request and publish information about the contributions of each person

named as having participated in a submitted study, at least for original research.

Editors are strongly encouraged to develop and implement a contributorship

policy, as well as a policy on identifying who is responsible for the integrity of the

work as a whole.

While contributorship and guarantorship policies obviously remove much of the

ambiguity surrounding contributions, it leaves unresolved the question of the

quantity and quality of contribution that qualify for authorship. The International

Committee of Medical Journal Editors has recommended the following criteria for

authorship; these criteria are still appropriate for those journals that distinguish

authors from other contributors.
• Authorship credit should be based on 1) substantial contributions to

conception and design, or acquisition of data, or analysis and

interpretation of data; 2) drafting the article or revising it critically for

important intellectual content; and 3) final approval of the version to be

published. Authors should meet conditions 1, 2, and 3.

• When a large, multi-center group has conducted the work, the group

should identify the individuals who accept direct responsibility for the

manuscript (3). These individuals should fully meet the criteria for

authorship defined above and editors will ask these individuals to

complete journal-specific author and conflict of interest disclosure forms.

When submitting a group author manuscript, the corresponding author

should clearly indicate the preferred citation and should clearly identify all

individual authors as well as the group name. Journals will generally list

other members of the group in the acknowledgements. The National

Library of Medicine indexes the group name and the names of individuals

the group has identified as being directly responsible for the manuscript.

• Acquisition of funding, collection of data, or general supervision of the

research group, alone, does not justify authorship.

• All persons designated as authors should qualify for authorship, and all

those who qualify should be listed.

• Each author should have participated sufficiently in the work to take public

responsibility for appropriate portions of the content.

Some journals now also request that one or more authors, referred to as

“guarantors,” be identified as the persons who take responsibility for the integrity

of the work as a whole, from inception to published article, and publish that

information.

Increasingly, authorship of multi-center trials is attributed to a group. All members

of the group who are named as authors should fully meet the above criteria for

authorship.

The order of authorship on the byline should be a joint decision of the coauthors.

Authors should be prepared to explain the order in which authors are listed.
II.A.2. Contributors Listed in Acknowledgments
All contributors who do not meet the criteria for authorship should be listed in an

acknowledgments section. Examples of those who might be acknowledged

include a person who provided purely technical help, writing assistance, or a

department chair who provided only general support. Editors should ask authors

to disclose whether they had writing assistance and to identify the entity that paid

for this assistance. Financial and material support should also be acknowledged.

Groups of persons who have contributed materially to the paper but whose

contributions do not justify authorship may be listed under a heading such as

“clinical investigators” or “participating investigators,” and their function or

contribution should be described—for example, “served as scientific advisors,”

“critically reviewed the study proposal,” “collected data,” or “provided and cared

for study patients.”

Because readers may infer their endorsement of the data and conclusions, all

persons must give written permission to be acknowledged.”

The Vancouver rules set forth three key conditions for coauthorship:
1) substantial contributions to conception and design, OR acquisition of

data, OR analysis and interpretation of data,

2) drafting the article OR revising it critically for important

intellectual content; and

3) final approval of the version to be published.
All three criteria must be met.
Table 1: The Vancouver rules’ main criteria for coauthorship
As shown by table 1, all three criteria must be met, but such that it is sufficient that one of the alternatives under 1 and 2 respectively have been met. This means that all the authors must have been involved in the intellectual process writing a scientific publication involves, see condition 2, and “the additional requirement” that all authors must have participated sufficiently in the work in order publicly to assume responsibility for suitable parts of the content of the publication. It must be underlined that these criteria have been under development. In Annex 2, the Commission has included a table showing how the key criteria looked at various points in time.

As can also be seen, the Vancouver rules differentiate between authors and contributors. Contributors who do not qualify as an author, by not meeting all three conditions, shall be stated and acknowledged in a separate section, “acknowledgement”. Examples of such contributors may be a person who assists solely in data collection, part analyses, technical help, writing assistance or more general support.



3.5.3 The relation of medical research to the Vancouver rules


The Vancouver rules do not legally represent any form of mandatory legislation. The criteria are in their nature guidelines which hold authority arising by the degree of compliance of the principles that take place in practice.

However, several of the publications referred to above show that the Vancouver rules to a varying degree are known among medical researchers, and that they also in a varying degree are accepted and practiced by the researchers who are familiar with the principles.

Based on the global impression the Commission has gained through its work, among other things, it seems that also within medical research in Norway, there are different perceptions of the authority of the Vancouver rules. The Commission’s impression is that the principles are not (or have not been) well

known in all research communities, although most people probably have “heard about” them. The Commission’s impression is also that the principles in certain research communities are practiced rather leniently.

The Commission underlines that these impressions are based on a limited material, but there is nevertheless reason to express these observations, in that it appears as obvious to the Commission that any such extensive deviating practicing – or non-practicing – of the Vancouver rules in a major part of the medical research community obviously will have to be taken into consideration when assessing whether there is a basis for criticism against the coauthors’ part in the case. The Commission’s impression at this point is moreover in harmony with the findings that are documented in international journals.

The Commission would in particular refer to a British study including 66 researchers which found that 76% supported criteria for authorship, but that few had any knowledge of or used available criteria. Of the five persons who could specify all three Vancouver rules, only one person knew that all three criteria are to be met.21

The study concluded that “there seems to be a gap between editors’ criteria for authorship and researchers’ practice”, and that “the strategy for communicating and implementing the criteria of the International Committee of Medical Journal Editors has largely failed. New initiatives should engage researchers and meet their legitimate needs. Future guidelines should be developed collaboratively and not be imposed on researchers by editors.”

Similar discrepancies between the Vancouver principles and that which is practiced in medical research communities in other countries have been documented in other articles.22

On the other hand, it is obvious that journals as well as research institutions must be able to practice and enforce the Vancouver rules as if they were binding, and not only guiding. That means that they may make demands that authors that publicize or work for them, follow these criteria. Thereby, the criteria will be seen as mandatory for these researchers. The management at the Radiumhospitalet, for example, has clearly stated to the Commission that the Vancouver rules apply to researchers at the institution, and that it is expected that they are followed. These requirements should be seen as a binding work instruction which the employer must be able to establish and enforce. However, it is unclear to the Commission whether this instruction has reached and is being practiced by the employees at the institution, and if so, to what degree.

3.5.4 The author responsibility


Based on the Vancouver rules and other rules for authorship, it may seem unclear what responsibility the individual author has when publishing research results. In the Commission’s opinion, this responsibility must be seen in the light of general liability rules, see section 3.3.

The implication for authors is that one must assume responsibility for what one has done, or as the case may be, not done, but ought to have done. Consequently, it is not necessarily the fact that one is mentioned as an author or coauthor that is decisive for the responsibility question but first and foremost what one in actual fact has done or not done. This also means that one must accept that individual authors are responsible for different elements, even when they act jointly, provided one is able to determine what the individual person has done. When several persons prepare a publication together, it is inherent in this that it is necessary to no little degree to build on and trust what a partner or other persons involved provide in the form of information of other parts of the research work. On the other hand it is of course possible that a coauthor or others will be held responsible because circumstances existed that indicated that one should have reacted and made further investigations.

However, to be an author does not imply that accepting (co-)authorship means almost signing a contract and becoming responsible for absolutely all parts of what is stated in the publication being correct. Such an interpretation has no basis or legitimacy in real life today, nor in the current version of the Vancouver rules, cf the requirement as to responsibility for “suitable parts”.

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