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

Abstract

Objective: To provide clarity on the professional medical writer as author or contributor by examining what “a substantial contribution” and “accountability” mean with respect to authorship in a biomedical publication. These terms relate to criteria 1 and 4 of the International Committee of Medical Journal Editors (ICMJE) authorship guidelines.

Methods: We reviewed the ICMJE and Good Publication Practice authorship guidelines, which recommend that individuals not meeting all four authorship criteria should be acknowledged as contributors. We also surveyed and assessed selected journals for published guidance on authorship versus contributorship.

Results: We found that journals often vary in their authorship guidelines for medical writers. Notwithstanding, and to assist in determining the contribution made by the medical writer, we have expanded on current guidelines to develop recommendations for important intellectual contribution to the design of the work (developing the protocol, choosing endpoints) or the interpretation of data for the work (developing the discussion, interpreting new statistical output), which should result in inclusion of the medical writer as an author, as well as when accountability is relevant. If the medical writer does not qualify as an author, then their inclusion in the acknowledgements section is appropriate.

Conclusions: Authors and contributors have a responsibility to create a publication that is accurate and true to the study results, but only authors must provide a substantial contribution and are accountable for that contribution. Contributions made by authors and non-author contributors should be fully described in the publication, to enable the reader to assess credit and responsibility.

Keywords:

• Authorship practices
• biomedical publications
• medical writers
• publication ethics

Transparency

Declaration of funding

There was no funding for this manuscript.

Author contributions: All authors were involved in the conception of the work. A.S. wrote the first draft of the manuscript based on conversations with all authors. All authors provided intellectual content, edited the manuscript, approved the final version for submission and agree to be accountable for all aspects of the work.

Declaration of financial/other relationships

A.S. has disclosed that she provides publication and regulatory medical writing services to various pharmaceutical companies. D.S. has disclosed that she is principal at and holds shares in Simcoe Consultants Inc., and provides publication consulting and medical writing services to various pharmaceutical companies. D.T. has disclosed that he is employed by and holds shares in Amgen Inc. L.D. has disclosed that she has been employed by various corporate entities, including Merck & Co. Inc., Sanofi Pasteur, Novartis Vaccines and EMD Serono.

A CMRO peer reviewer on this manuscript is a member of the International Society for Medical Publication Professionals (ISMPP) Ethics & Standards Committee. Other CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

A.S., D.T., L.D. and CMRO Senior Editor, Tanya Stezhka, were members of the ISMPP Ethics & Standards Committee at time of publication. CMRO is a founding member of ISMPP.

Acknowledgements

We thank Catherine Skobe MPH MT(ASCP) of Pfizer, New York, NY, USA for her early input to the manuscript.

The opinions expressed in the manuscript are those of the authors and do not necessarily reflect the opinions of their employers or CMRO Journal.