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COPE guidelines on good publication practice
  1. MICHAEL DOHERTY
  1. Academic Rheumatology
  2. Clinical Sciences Building
  3. City Hospital
  4. Nottingham NG5 1PB, UK
  5. Email: michael.doherty{at}nottingham.ac.uk
  6. University Hospital Nijmegen
  7. Department of Rheumatology
  8. PO Box 9101
  9. 6500 HB Nijmegen
  10. The Netherlands
    1. LEO B A VAN DE PUTTE
    1. Academic Rheumatology
    2. Clinical Sciences Building
    3. City Hospital
    4. Nottingham NG5 1PB, UK
    5. Email: michael.doherty{at}nottingham.ac.uk
    6. University Hospital Nijmegen
    7. Department of Rheumatology
    8. PO Box 9101
    9. 6500 HB Nijmegen
    10. The Netherlands

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      The Committee on Publication Ethics (COPE) was founded in 1997 by a group of UK medical editors who wished to discuss specific examples of possible research and publication misconduct that they were currently facing. A few, such as the editors of theLancet and BMJ, were full time professional editors with a large publishing staff and ready access to expert advice. Most, however, were more isolated part time editors who had received no formal training in publication issues. Additional committee members provided expertise on medical ethics, law, and the practical consequences of actions such as “whistle-blowing”. The discussions of cases by COPE, published regularly in anonymised form,1 2 focus on the practicalities of whatshould and what couldbe done in each specific case. These case discussions have proved useful not only to guide appropriate action in individual situations but also as a learning resource for other editors. Importantly, such illustrative cases have highlighted the need for more generic guidelines for good practice on a wide spectrum of research and publication issues.

      In April 1999 COPE organised an open one day meeting in London to discuss draft guidelines on good publication practice. Attendance was good with input not only from European and North American editors but also the UK General Medical Council, the Royal College of Physicians, and the pharmaceutical industry. The various research and publication misdemeanours that may be unearthed by the editorial and peer review process were fully debated. The emphasis, however, was onwhat actionshould be taken by the editor once possible misconduct was suspected or confirmed. The guidelines were modified in the light of those discussions and are now published2 and available on the web site: www.publicationethics.org.uk

      Although of potential interest to a wide and diverse audience, these guidelines mainly address practical issuesand therefore are of particular value to authors, editors, editorial board members, and peer reviewers. The first part of the guidelines considers 10 specific areas—namely:

      • Study design and ethical approval

      • Data analysis

      • Authorship

      • Conflicts of interest

      • Peer review

      • Redundant publication

      • Plagiarism

      • Duties of editors

      • Media relations

      • Advertising.

      Each is firstly defined and then appropriate standards and conduct for each are specified under “action”. For example, the sections on “Study design” read as follows:

      Definition

      Good research should be well justified, well planned, appropriately designed, and ethically approved. To conduct research to a lower standard may constitute misconduct.

      Action

      (1)
      Laboratory and clinical research should be driven by protocol; pilot studies should have a written rationale.
      (2)
      Research protocols should seek to answer specific questions, rather than just collect data.
      (3)
      Protocols must be carefully agreed by all contributors and collaborators, including, if appropriate, the participants.
      (4)
      The final protocol should form part of the research record.
      (5)
      Early agreement on the precise roles of the contributors and collaborators, and on matters of authorship and publication, is advised.
      (6)
      Statistical issues should be considered early in study design, including power calculations, to ensure there are neither too few nor too many participants.
      (7)
      Formal and documented ethical approval from an appropriately constituted research ethics committee is required for all studies involving people, medical records, and anonymised human tissues.
      (8)
      Use of human tissues in research should conform to the highest ethical standards, such as those recommended by the Nuffield Council on Bioethics.3
      (9)
      Fully informed consent should always be sought. It may not always be possible, however, and in such circumstances, an appropriately constituted research ethics committee should decide if this is ethically acceptable.
      (10)
      When participants are unable to give fully informed consent, research should follow international guidelines, such as those of the Council for International Organisations of Medical Sciences (CIOMS).4
      (11)
      Animal experiments require full compliance with local, national, ethical, and regulatory principles, and local licensing arrangements. International standards vary.
      (12)
      Formal supervision, usually the responsibility of the principal investigator, should be provided for all research projects: this must include quality control, and the frequent review and long term retention (maybe up to 15 years) of all records and primary outputs.

        Similarly, this is the section on “Duties of editors”:

      Definition

      Editors are the stewards of the journals. They usually take over their journal from previous editor(s) and always want to hand over the journal in good shape. Most editors provide direction for the journal and build a strong management team. They must consider and balance the interests of many constituents, including readers, authors, staff, owners, editorial board members, advertisers, and the media.

      Action

      (1)
      Editors' decisions to accept or reject a paper for publication should be based only on the paper's importance, originality, and clarity, and the study's relevance to the remit of the journal.
      (2)
      Studies that challenge previous work published in the journal should be given an especially sympathetic hearing.
      (3)
      Studies reporting negative results should not be excluded.
      (4)
      All original studies should be peer reviewed before publication, taking into full account possible bias due to related or conflicting interests.
      (5)
      Editors must treat all submitted papers as confidential.
      (6)
      When a published paper is subsequently found to contain major flaws, editors must accept responsibility for correcting the record prominently and promptly.

         The second part of the guidelines summarises the principles involved when dealing with suspected misconduct, advises on how to investigate both serious and less serious misconduct, and then suggests eight possible sanctions that may be applied (separately or in combination and ranked in approximate order of severity). Finally, details of other guidelines on research ethics and published codes of conduct are listed in an Appendix.

      COPE has no statutory powers and the guidelines are intended to be advisory rather than prescriptive. Although COPE consulted widely in the development of the guidelines, it is expected that they will evolve with time. They will be reviewed and refined as necessary each year.

      In common with many editors of other biomedical journals these gguidelines were endorsed by the editor of theAnnals, who feels that they usefully summarise acceptable, expected standards of conduct by authors, reviewers, and editors. The Annals has a tradition of interest in all aspects of professional conduct relating to research and publication, and has recognised the importance of appropriate process and editorial responsibility when misconduct arises.5 We hope that submitting authors and reviewers for the Annals will read the COPE guidelines with interest and join the editor and his board in advancing awareness of the issues involved, and in promoting the highest standards of ethical conduct for research and publication.

      References

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