Publication and medical writing 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 and journal editors.

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. All studies must meet international ethical guidelines.

At Edanz, we support transparent and ethical publication policies, and will never knowingly support malpractice.

What do publication ethics refer to?

  • Publication planning– duplicate publications should be avoided
  • Data transparency– all results should be disclosed, including negative results
  • Authorship– what qualifies someone as an author, and what are their responsibilities
  • Sponsorship– declaration of funding and involvement of sponsors
  • Role of the medical writer

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/oral presentations) 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 the journal should be consulted if there is 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 who 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, and
  2. Drafting the article or revising it critically for important intellectual content, and
  3. Final approval of the version to be published, and
  4. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved

Authors should meet all four conditions.4

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

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), and post results in accordance with local regulations
  • Make use of publication planning to ensure 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 Group medical writers as assisting in the writing of the manuscript

Working with Edanz

  • Edanz works in accordance with the guidelines set out in GPP3 6
  • Our processes and procedures are designed to ensure that each project (especially manuscript development projects) is carried out in accordance with both the guidelines and principles set out in international best practice recommendations, such as GPP3.

References

  1.  http://www.icmje.org/index.html
  2. http://www.publicationethics.org.uk/guidelines/code
  3. http://www.nejm.org/doi/full/10.1056/NEJM199111073251910
  4. http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html
  5. http://www.thelancet.com/lancet/information-for-authors
  6. http://annals.org/article.aspx?articleid=2424869

 

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Edanz follows a professional code of ethics and has instituted measures ensuring the confidentiality of the manuscripts and all documentation sent to us by our clients. All Edanz writers, staff and directors sign legally binding Confidentiality Agreements with Edanz.

Personal information and manuscript data are never shared beyond your assigned writers and the in-house Edanz staff. Unlike some services, Edanz does not outsource project processing. We guarantee the confidentiality and security of your data at all stages of the project process.
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Non-disclosure

If required, we can provide you with a non-disclosure agreement (in English) before we begin work on your medical writing project.