Are ICMJE authorship guidelines leaving people out?

The most widely referenced and followed guideline for authorship of scientific publications is that issued by the International Committee of Medical Journal Editors (ICMJE). In it, the ICMJE recommends that authorship be determined by:

  • Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
  • Drafting the work or revising it critically for important intellectual content; AND
  • Final approval of the version to be published; AND
  • 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.

The ICMJE states that

All those designated as authors should meet all four criteria for authorship, and all who meet the four criteria should be identified as authors. Those who do not meet all four criteria should be acknowledged.

A recent study looked at challenging authorship scenarios and asked clinical investigators, medical journal editors, publication professionals, and medical writers to decide who should be granted authorship status in these situations and how confident they were in their decision.

Results of the survey study showed several cases where there were higher levels of disagreement between the groups surveyed than other cases. For instance, respondents were asked whether a statistician who made a significant contribution to the study but did not participate in study design or drafting the manuscript should be listed as an author. In this scenario, 54% of clinical investigators surveyed would grant the statistician authorship whereas 72% of publication professionals surveyed would grant authorship.

From these and other survey results, the study authors proposed a revised method to determine who should be listed as an author on scientific publications. Their Five-Step Authorship Framework consists of:

  1. Establish an authorship working group of core trial contributors as close as possible to trial commencement but prior to enrollment of first patient.*
  2. Determine, in the context of the ICMJE authorship criteria and the specific trial, which authorship contributions will qualify as ‘substantial’ and include these details in written publication agreements for all trial contributors.
  3. Implement a process to track and document in a concise format progress toward substantial contributions based on agreed-upon qualifications.
  4. Assess documented trial contributions for the specific study and invite those making a ‘substantial contribution’ to participate as author(s).
  5. Ensure invited authors meet remaining ICMJE authorship criteria during content development and publication submission.

The authors note that

utilizing the experience and judgment of a diverse group of core trial contributors in an open discussion format provides a transparent process for determining fair and comprehensive authorship criteria for a given trial

and suggest that any authorship guidelines developed by the working group should align with other guidelines to avoid potential bias.

Luckily, I have yet to experience a scenario where there was a major disagreement over who should be listed as an author or how somebody’s contributions fit in with the ICMJE guidelines. As a medical writer, I was interested to see that almost a quarter of the journal editors and clinical investigators surveyed supported listing medical writers as authors.

*For smaller trials where an authorship working group is not feasible, this committee may be a sub-committee of a larger Trial Steering Committee where one exists.