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Case discussion: Authors’ contributions and involvement by medical communications company

Case Summary

Case 14-07 Authors' contributions and involvement by medical communications company

An employee of a medical communications company contacted a journal’s editorial office. For several manuscripts, the employee had helped develop the narrative based on an outline, added references, and addressed peer review comments. However, the authors had minimal involvement and demonstrated limited understanding of the study. One such manuscript was being considered by the journal. The authors had acknowledged language editing but not developmental editing by the company. In addition, the cover letter contained inaccuracies about the study. When asked about the cover letter, the authors said they had used a template from the company and the paper had been the first of this type they had written. The journal office planned to investigate further, without exposing the whistleblower.

Question(s) for the COPE Forum

  • Should the journal proceed to contact the authors regarding the contributions to the manuscript?
  • What is the journal’s duty towards the person who raised the concerns?
  • Are there any steps that can be taken to identify this type of situation in the future?

Forum advice and follow-up

The Forum advised asking the authors to clarify further, while keeping the whistleblower anonymous. For example, the journal editor could investigate the authors’ knowledge of the study or non-author names in the document ‘properties’. The Forum considered this case as clearly demonstrating ghost writing and advised rejecting the paper and asking the authors’ institution to investigate. To deal with the medical writer, the editor could check if s/he belongs to and follows codes of conduct of the American Medical Writers Association (AMWA), European Medical Writers Association (EMWA), or International Society for Medical Publication Professionals (ISMPP).

In reply to the editor, the authors said the medical communications company helped only after they had made the rough draft. However, the file of the rough draft that the authors sent the editor showed only the medical writer’s name as the author, sustaining concerns about the extent to which the authors had designed and written up the study. Consequently, the editor rejected the manuscript, reported the case to the authors’ institution, and considered the case closed. The journal is seeking ways to systematically identify similar cases in the future.

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Case discussion

This case mainly deals with COPE’s Core Practice of Authorship and Contributorship, which states: “Clear policies (that allow for transparency around who contributed to the work and in what capacity) should be in place for requirements for authorship and contributorship as well as processes for managing potential disputes”.

Also relevant is COPE’s Core Practice on Allegations of Misconduct, which states: “Journals should have a clearly described process for handling allegations, however they are brought to the journal's or publisher’s attention. Journals must take seriously allegations of misconduct pre-publication and post-publication. Policies should include how to handle allegations from whistleblowers”.

While maintaining whistleblower anonymity, journals need to investigate alleged cases of misconduct that affect the authorship of and hence credit and accountability for a work. First, however, journals need to have a clear definition of authorship in their guidelines. Authorship criteria for medical journals may or may not be based on those in the recommendations of the International Committee of Medical Journal Editors (ICMJE). According to the COPE discussion document on authorship (soon to be revised), journals could also request authors to sign an authorship declaration as a condition of publication. Signatories should fulfil the journal’s authorship criteria and state their contributions (to avoid gift and guest authorship), as well as declare that nobody who deserves authorship has been omitted (to avoid ghost authorship). It is unclear in the case described whether the journal had these policies in place. Journals that do can then remind authors of those policies when asking them to justify and clarify authorship, as outlined in the COPE flowchart on suspected ghost, guest, or gift authorship. Journals may find the Contributor Roles Taxonomy (CRediT) useful for declarations of author contributions.

Contributors who do not qualify for authorship should be named in the Acknowledgements, with their written permission. In this case, a third party was not properly acknowledged for the nature and extent of assistance provided (far beyond the language editing declared), leading the COPE Forum to conclude that ghost writing had occurred (ie, undeclared writing help). The journal’s inspection of author files revealed that the first draft had been written by the third party and not by the authors as claimed. This finding corroborated the whistleblower’s allegations that the authors lacked involvement in and knowledge of the study, and thus suggested ghost authorship. Although the COPE flowchart on suspected ghost, guest, or gift authorship suggests listing an identified ghost author as an author if the other authors agree, this case implied that the named authors were in fact guest authors. The paper seemed to be unethically prepared from the outset, prompting the editor to refer the case to the authors’ institution. 

It is not stated, but likely in this case, that the submitted study report is some sort of review paper. When third parties are asked to assist with literature searches, qualitative or quantitative analyses, and narrative development of review papers, writing assistance might veer into (co)authorship because the reviewing, synthesis, and message development processes are themselves integral parts of a secondary research study. The extent of involvement depends on the nature and stage(s) of work and actual input and direction from the supposed authors. Journals may have specific guidelines on the use of third parties, and medical journals should at least reference the Good Publication Practice (GPP) guidelines, now in their third edition (GPP3). The guidelines, endorsed by COPE, cover ethical publication, authorship, and acknowledgements for company-sponsored medical research. They also note that medical writers may qualify for authorship if they meet ICMJE or journal-specific authorship criteria, which is possible if they contributed substantially to a review.

Being honest and complete in both the author list and Acknowledgments section is important for transparency not only in contributorship, but also in disclosing any conflicts of interest and hence possible bias in the work. Ghost authorship and ghost writing (and ghost editing or other editorial assistance) may hide conflicts of interest related to sponsors, funders, and company owners. Conversely, funding and other potential conflicts of interest must be included when providers of editorial or publishing support services, or employees of any other third parties, are named as authors or thanked in the Acknowledgements. Furthermore, the names of specific people and their employers are needed, as well as the specific type of assistance provided. Wording for Acknowledgements of medical writing assistance, as recommended in the AMWA‒EMWA‒ISMPP Joint Position Statement on the Role of Professional Medical Writers, is as follows:

“The authors thank [name and qualifications] of [company, city, country] for providing medical writing support/editorial support [specify and/or expand as appropriate], which was funded by [sponsor, city, country] in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).”

Finally, in addition to strengthening authorship and acknowledgement policies, clarifying relevant guidelines, and requiring authorship declarations at submission, journals can systematically check for unusual patterns of behaviour that may suggest authorship problems. The COPE infographic “How to recognise potential authorship problems” has some useful hints and tips in this regard.

COPE Council Member, Trevor Lane on behalf of the COPE Education Subcommittee

 

Read June 2019 Digest newsletter with an introduction from Deborah Poff, COPE Chair, introducing some of the issues raised around predatory publishing, at meetings and conferences attended in 2019 and in developing the third iteration of our Predatory Publishing Discussion Document. Read a summary from panel members on the Authorship and Transparency discussions at the World Conference on Research Integrity (#WCRI2019). New and updated cases presented at the COPE Forum in May are now available online. Keep abreast of news & events in #PublicationEthics as collated by COPE Council members.