Substantial contribution and accountability: best authorship practices for medical writers in biomedical publications

Figures & data

Table 1. Journal opinions on the role of the medical writer as author or contributor. Examples are provided of journals’ views on medical writers as authors or contributors, the relationship of the respective journal to the ICMJE, and a statement taken directly from the journal’s author guidelines or editorial policies*.

Journal guidance for medical writers as authors or contributors
BioMed Central journals (refer to ICMJE guidelines^2)	The involvement of scientific (medical) writers or anyone else who assisted with the preparation of the manuscript content should be acknowledged, along with their source of funding, as described in the European Medical Writers Association (EMWA) guidelines. The role of medical writers should be acknowledged explicitly in the “Acknowledgements” or “Authors’ contributions” section as appropriate.
Blood (member of ICMJE journal list^2)	Any involvement by pharmaceutical or medical device company employees or medical writers supported by a pharmaceutical or medical device company in the writing of an article must be clearly defined and disclosed in the Conflict-of-interest Disclosure section of the manuscript (if the individual is an author) or the Acknowledgments section (if the individual is not an author).
Journal of Antimicrobial Chemotherapy (refers to ICMJE guidelines^2)	Professional medical writers and other forms of writing assistance have an important role to play in the clear communication of scientific results. However, unless this role is openly explained and acknowledged unfounded suspicions about this role will continue. JAC encourages the open and precise description of any such assistance received by authors in relation to any article. It is possible that writers may qualify for authorship of a manuscript, we recommend that authors review the ICMJE criteria for authorship before submission.
Journal of Managed Care & Specialty Pharmacy (refers to ICMJE guidelines^2)	A medical writer who interprets the data and writes the manuscript, for example, should generally be a listed author. Failure to recognize a writer who meets authorship criteria is known as “ghost writing” and is unethical. On the other hand, a person who primarily reviews a manuscript and makes minor editorial changes does not generally qualify as a listed author. This latter situation has occurred when experts were solicited to serve as authors because of their position or recognition in a field of study. Thus, it is important that solicited authors’ consultative roles are assessed for congruency with authorship criteria.
The Lancet (signatory member of ICMJE journal list^2)	We require signed statements from any medical writers or editors declaring that they have given permission to be named as an author, as a contributor, or in the Acknowledgments section.
Journals requiring medical writers to be authors and their authorship definition
Dermatologic Surgery (refers to ICMJE guidelines^2)	Authorship practices such as “ghost” authorship (individuals who qualify for authorship or who have made a contribution but who are not listed either as authors or as contributors) are inappropriate. This includes professional medical writers and their names, affiliations, and conflicts of interest must be included among the authors.
Neurology (member of ICMJE journal list^2)	Neurology defines an author as a person who has made a substantive intellectual contribution to the submitted manuscript. A substantive contribution includes one or more of the following:Design or conceptualization of the study; OR analysis or interpretation of the data; OR drafting or revising the manuscript for intellectual content. Professional writers employed by pharmaceutical companies or other academic, governmental, or commercial entities who have drafted or revised the intellectual content of the paper must be included as authors.Neurology defines a Contributor as a person who does not meet the criteria for authorship of the study, but who has contributed in other ways, such as collection of data; technical assistance; acquisition of funding; supervision of personnel; contribution of drugs, reagents, equipment, or participants; or editing the manuscript for nonintellectual content.
Health Services Research and Managerial Epidemiology; Translational Epigenomics (SAGE publications) (refer to ICMJE guidelines^2)	Manuscripts submitted for publication must list all authors, including the person who drafted the original manuscript. This includes paid or unpaid medical writers (“ghost writers”). If medical writers are to be involved in the preparation of manuscripts then they must co-author with a clinician (or other medical professional) and their name and full affiliation must appear on the article. The work of any medical writer must not be passed off as that of a clinician or other medical professional.
Journals proposing that medical writers are included in the acknowledgements
European Journal of Pain; International Journal of Laboratory Hematology (Wiley publications) (refer to EMWA and COPE guidelines^4^,^7)	Please name any professional medical writer among the list of contributors to any article for the journal (not only original research papers), and specify in the acknowledgments and statement of competing interests for the article who paid the writer.
The Oncologist (member of ICMJE journal list^2)	If an article has been substantially written by a contracted writer not named in the byline, this fact needs to be noted in the Acknowledgments section of the manuscript. In addition, all other contributors who do not meet sufficient criteria for authorship should also be noted in the Acknowledgments section.

*Selection of journals was by manual searching using keywords “authorship guidelines” and “medical writer”; search performed 28 January 2018.

Abbreviations. COPE, Committee on Publication Ethics; EMWA, European Medical Writers Association; ICMJE, International Committee of Medical Journal Editors; JAC, Journal of Antimicrobial Chemotherapy.

Table 2. Recommendations for designation of substantial contribution for the medical writer to qualify for authorship.

Substantial contributions^a^,^b	Non-substantial contributions
Interpreted the data and wrote the first full draft of the manuscript, including outline.	Edited the manuscript for grammatical mistakes or data errors.
Developed discussion points based on review of the data and published literature.	Reformatted an outline or manuscript provided by an authoring team for a new journal.
Performed a literature review that facilitated the data interpretation and wrote the first draft of the manuscript, including interpretation of literature for the introduction and interpretation of the trial data for the discussion.	Performed technical editing, language editing and proofreading, and collated comments from authors.
Developed the (primary) publication from a clinical trial report written by another writer and developed it further, including performing and interpreting a literature review and interpretation of the data.	Developed the (primary) publication with input from the authors, and did not perform a literature review or provide additional interpretation of data in the introduction or discussion.
Developed the (primary) publication from a clinical trial report that the medical writer wrote and in which their own interpretation was applied to the discussion.	Drafted the methods and results sections of the manuscript while an author or authors drafted the introduction and discussion sections.
Contributed to trial design by choosing endpoints or clarifying specifics of trial intervention.	Reviewed the manuscript or protocol for consistency between sections without finding or addressing major errors.
Provided intellectual input to or interpretation of statistical output developed for a secondary manuscript, which the medical writer then drafted.	Summarized a literature review performed by a scientist or medical expert^c.
Wrote substantial portions of the protocol or data analysis plan or trial report and manuscript.	Composed the draft methods and results based on primary outcomes in a trial report.
Designed tables and figures and provided intellectual input/decisions for the selection of specific noteworthy data to enable correct interpretation of meaningful results.	Copied and pasted tables from a trial report under direction from a trial investigator. Reformatted tables for a specific journal style.
Contributed to a search-term or meta-analysis design and composed the first full draft of a manuscript.	Made a table of bibliographic information from papers derived from a literature search.

^aIt is assumed that the additional authors on the paper each qualify as such according to the ICMJE criteria and are actively engaged in the manuscript development process.

^bIn each of these cases, the medical writer has provided a substantial contribution to the design of the work, or the interpretation of data for the work.

^cAuthors should be provided with full access to data from the study, while maintaining subject confidentiality. Full access would mean access to sponsor documents such as the protocol, clinical trial report, including tables and figures, statistical analysis plan and any additional statistical output.

ICMJE. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals: Updated December 2017. Available at: http://www.icmje.org/icmje-recommendations.pdf [Last accessed 28 January 2018]

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Jacobs A, Wager E. European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications. Curr Med Res Opin 2005;21:317-21

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Committee On Publication Ethics (COPE). Code of conduct and best practice guidelines for journal editors. 2011. Available at: http://publicationethics.org/files/Code%20of%20Conduct_2.pdf [Last accessed 12 December 2017]

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