Medical publication policies and guidelines offer a framework for best practices, but there may be situations when more than one approach seems reasonable. The primary purpose of “What Would You Do?” is to explore examples of such situations. With the limited information provided to interpret the scenarios, you may find yourself agreeing with one, more than one, or none of the proposed actions. And that’s the point ‒ you should debate, contemplate, and communicate (with a comment) before selecting your “best” answer. 

Now let’s find out how you responded and read through some commentary (for context only; not meant to be comprehensive) to the below scenario:

You are the Scientific Director of a medical communications agency who is working with the Publications Director at a large pharmaceutical company. An external author posts the first draft of a preclinical manuscript on his/her department preprint server to invite review and comments from colleagues who performed some of the work yet did not meet all ICMJE criteria for full authorship. This author is now petitioning the author group to add one more colleague who provided insightful comments to the author byline.

What Would You Do?

A. Ask the recommending and potential new author to provide a list of the candidate’s contributions and share this with all authors. If all authors approve, then add the new author to the byline.

B. Suggest acknowledging the contributions of the newly recommended author in the Acknowledgements section.

C. Contact the lead and senior authors for their input and proceed following their direction.

D. Remind the author who made the recommendation that all authors must meet ICMJE criteria. As this was not established at manuscript initiation, it would not be appropriate to add an author at this stage of development.

A total of 41 people replied to this poll.

Here are some select factors to consider in a scenario such as this one (with the involvement of an industry publications director, it will be assumed this is a company-sponsored study that has been circulated for review by the agency):

  • Is the publication still in an early stage of development? The farther along a publication is in development, the fewer opportunities for significant changes to the content, and the stronger the justification needed to alter authorship. An “early stage” can be defined as before writing begins, during the development of the outline, or up until the review of the 1st draft.
  • Do the “insightful comments” meet ICMJE authorship criteria, and do they result in substantial alterations to the manuscript content? A key consideration is whether the “insightful comments” meet the latter part of ICMJE criterium #1 of substantial contributions to the interpretation of data for the work (presumably the colleague did not contribute significantly to the conception, design, acquisition, or analysis of data, otherwise he or she would probably have been invited to be an author) [1]. Another important consideration is whether the input results in additional analyses, as agreed by the authors, that will substantially alter the original results and communication points of the publication. It would also be necessary for the individual to have the opportunity for continued involvement with the manuscript to fulfill all authorship criteria.
  • Was authorship previously discussed and agreed upon? A stronger justification would be needed to include another author if authorship was previously discussed. For clinical trials with many investigators and/or studies with publication steering committees (which are not common for preclinical studies), early alignment on authorship based on contributions and expected fulfillment of ICMJE criteria supports transparency and limits the number of authors. This also helps avoid the precedent of an author inviting a sub-investigator or other collaborator to review a manuscript with the expectation of authorship, as well as the perception of guest authorship. For industry-sponsored manuscripts, there are often comments received from multiple industry reviewers from different business functions, but they are not typically considered for authorship and their contributions are usually acknowledged instead.
  • Is it appropriate to consider the colleague as an author and/or the comments as officially received? Although it was stated that the colleague was involved in the study, should he or she have had access to the manuscript? Companies undergo great effort to have signed author agreements in place so that they do not share confidential information with third parties; the appropriateness of posting the manuscript on a department-wide platform for others to review should be considered, with direction from legal and/or healthcare compliance, and likely investigated.

Ultimately, Option A may be the most appropriate approach as the discussion could be used to assess and determine whether the opportunity to serve as an author, an acknowledgement, or neither is the proper path as it relates to good publication practice [2] and company policies.

Eric Y. Wong, PhD, MBA, ISMPP CMPPTM, Janssen Global Services, LLC

This article was prepared by the author in his personal capacity. The opinions expressed within are the author’s own and do not necessarily reflect the views of Janssen Global Services, LLC.


  1. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (updated December 2019):
  2. Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3: Ann Intern Med. 2015 Sep 15;163(6):461-4. doi: 10.7326/M15-0288
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