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 providing medical writing support on a manuscript for which all non-industry authors are from a non-English-speaking country. The manuscript is written in English, but it is clear from the kick-off call that very few of the non-industry authors have a good understanding of English. The industry authors recommend that all communication goes through them so that they can interact with the non-industry authors in their local language and obtain their review feedback and approval. Although an appropriate level of comments is received throughout the manuscript’s development from industry authors, they indicate (usually within 24 hours of the start of each review) that all non-industry authors are happy with the content. You are now ready to initiate the author approval step but have concerns that the non-industry authors do not meet all the International Committee of Medical Journal Editors (ICMJE) criteria for authorship.
- Suggest that an independent third party, such as a translation service or local branch of the medical writing agency, become involved to document/capture the reviews up to now before proceeding to final approval
- Proceed with the final author approval step
- Work with the industry authors to obtain documentation of author reviews before proceeding to final approval
- Suggest that the final draft of the manuscript be translated into the local language for the final approval step
A total of 69 respondents replied to this poll.
Ideally, all publication drafts would be available in the native languages of the authors for review, but this may not be typical or feasible as it is resource intensive to factor in translations, and most authors generally understand written English. Moreover, global companies often have local and/or multi-lingual employees (eg, medical/clinical teams or medical science liaisons) who can aid in communication with authors. Translation services should be factored in as part of publication development plans if a company often deals with this issue or a study warrants such support.
Aside from language itself, lack of understanding of ICMJE criteria1 and/or cultural norms may also lead to passivity, which is opposite of the active participation normally expected from authors. Scheduling meetings to review the content and document discussion points can be a useful tactic to confirm author contributions if communication through emails or a publication management platform does not fully engage the authors. Finally, it is a good practice to align early on the expectations of authors and processes for capturing comments (eg, during author invitation or publication kickoff discussions), particularly when addressing publications with non-English-speaking authors.
With these points in mind, we can explore the different options:
Proceed with the final author approval step (2% of responses)
If a medical writer has any concerns regarding qualification for authorship, they should be brought up to the authors for reconciliation before proceeding with final author approvals.
Suggest that the final draft of the manuscript be translated into the local language for the final approval step (16% of responses)
If there is time and budget for this step, it would certainly be helpful. Otherwise, a company employee or local representative who is fluent in the language can work with the authors to document contributions and align on the content because the authors must give final approval and agree to be accountable for the content per ICMJE criteria.
Note that publications translated into another language are generally not considered duplicate publications, and a potential benefit is that the translated manuscript may be considered for publication in the other language after the primary English version is published.2
Suggest that an independent third party, such as a translation service or local branch of the medical writing agency, become involved to document/capture the reviews up to now before proceeding to final approval (33% of responses)
With a translation service, the considerations are like those of translating the manuscript for final approval (see above). However, it can be challenging to bring in an agency near the final stages of a manuscript to go back and capture review steps that have already occurred. The lack of background and initial involvement by the agency could result in an inefficient, time-consuming, and costly process that could even potentially complicate matters.
Work with the industry authors to obtain documentation of author reviews before proceeding to final approval (49% of responses)
The most common practice is probably medical writers and industry authors working together to properly document contributions. Industry authors are in position to collaborate and obtain documentation from non-industry authors throughout the manuscript development process because they go through the same steps. Moreover, there may already be relationships in place between industry and external authors as they often work together on study conception, study design, and acquisition of data. Finally, industry authors can also enlist the assistance of local employees who can help document comments from non-English-speaking authors.
Eric Y. Wong, PhD, MBA, ISMPP CMPPTM, Janssen Scientific Affairs, 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 Scientific Affairs, LLC.
- Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (updated December 2019): http://www.icmje.org/icmje-recommendations.pdf
- 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.