Publication ethics

A well written manuscript that fulfills ethical considerations is more likely to be considered for publication and reviewed favorably.

Recent developments in the medical/pharmaceutical field mean that an awareness of publication ethics is paramount, not just for authors, but also study sponsors, study investigators, journal editors, and service providers such as Edanz Writing.

The following serves as a brief introduction to publication ethics. We recommend reading the sources noted here to ensure you are familiar with the recommendations.1,2 This does not, however, provide a complete review of study ethics, processes or requirements. Suffice to say, all studies must meet ethical guidelines.

At Edanz Writing, we support transparent and ethical publication policies.

What do publication ethics refer to?

  • Publication planning– duplicate publications should be avoided
  • Authorship– what is an author and who can qualify
  • Sponsorship– declaration of funding and involvement of sponsors
  • Role of medical and science writers
  • Our recommendations

Publication planning

What data can be published in journals? The Ingelfinger rule

The Ingelfinger rule was initially proposed in 1969 by Franz J. Ingelfinger (the then Editor of the New England Journal of Medicine) in an attempt to protect the journal from publishing material that had previously been published (thus preventing publication of unoriginal material or duplicate publications).3 Similar policies have been adopted by most (if not all) international journals.

There are some exceptions to the rule:

  1. Publication of results in abstract form (and posters/orals) at local, national or international congresses
  2. Posting of results in a Clinical Trial depository, as required by local/national/international laws
  3. Translation and publication in alternative languages: Journal policies may differ and authors should check with the journal if in any doubt

Presentation of results at congresses can provide a rapid route for presentation of data. Once a manuscript has been published, data should not then be submitted to a congress.

The recent introduction of clinical trial registries and legal requirements for publication of data in a publicly available registry is a positive step forward to help protect medical healthcare. Some regions require the rapid publication of results in such a depository upon completion of a clinical study. Implications for journal publication are less clear, but if acknowledged, and if the extent of interpretation of data is minimal (e.g., with a length similar to an abstract), this should not preclude publication.

Authorship

Who is an author?

Traditionally, authorship has been granted to people involved in the research and had some role in developing the manuscript. The ICMJE now recommends that authorship is ‘awarded’ based on:

  1. Substantial contributions to conception and design, 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 all three conditions.4

We advocate that the Acknowledgments should list any individuals who have provided assistance (e.g., technical, experimental, statistical support and writing assistance).

Some journals, including The Lancet, now recommend a summary of the contribution of each author, including study design, data collection, interpretation of the data, and writing the report, as well as financial disclosure.5

Study sponsorship

Increasingly, studies are funded externally, either by research grant support or by direct funding from a healthcare/biomedical company, for example. Accordingly, the source of financial support should be stated in the Acknowledgments.

Clinical studies are routinely being sponsored by healthcare/biomedical companies, with employees listed as Authors. This in itself is not necessarily detrimental, as company authors may provide a greater role in terms of relative contribution to managing the study and writing the final report. However, it is important to acknowledge the precise role of the Sponsor.6

Role of Medical Writers and Editors

Medical Writers and Editors are increasingly being given responsibility in terms of drafting, editing and incorporation of author comments. However, Medical Writers and Editors do not meet the full ICMJE guidelines, as they do not provide any input into the design or running of a study. Nevertheless, we advocate acknowledgment of the Writer and Company as this can actually add rather than detract from the merit and acceptance of the publication, especially for non-native English language authors.

Our recommendations:

  • Seek ethical approval for the study from the appropriate Ethics Committee/s
  • Register clinical studies on a relevant database (e.g., www.clinicaltrials.gov) post results in accordance with local regulations
  • Publication planning ensures no unwarranted duplicate publication
  • Authors should provide substantial input and meet the ICMJE criteria for authorship
  • List the actual author contributions
  • Provide full conflict of interest statements for all authors
  • Fully acknowledge the role of the funding source
  • Acknowledge Edanz Writing (and the lead writers) as assisting in the writing of the study

References

1 http://www.icmje.org/index.html
2 http://www.publicationethics.org.uk/guidelines/code
3 http://www.nejm.org/general/text/policies.pdf
4 http://www.icmje.org/index.html#author
5 http://www.thelancet.com/authors/lancet/authorinfo
6 http://www.thelancet.com/authors/lancet/authorinfo