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

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.