The unethical practice of ‘ghost-writing’ or non-disclosure of medical or freelance writers employed to write journal articles led to the development of guidelines for ethical and transparent publication practices by the International Committee of Medical Journal Editors (ICMJE). These were first published as early as 1979, and were recently updated in the GPP3 guidelines. ICMJE defines authorship according to the following criteria:
- 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.
“In their current state, the ICMJE authorship criteria also generally preclude medical writers from being authors because they usually cannot (or are unwilling to) satisfy criteria 3 and 4.” (Phil Leventhal, 2016 Medical Writing Vol 25:1)
In the context of scientific or medical publishing, the roles of professional writers and authors are not the same. Professional writers are accredited by various professional societies mainly for expertise in technical writing. But the question of who is responsible for the accuracy of the manuscript in terms of the data that is analysed and reported, can be a ‘grey area’ in publications by commercial entities.
Inaccurate data can be just as clearly and concisely written up as accurate data, and few will know the difference. However, the fact remains, publications of inaccurate data are essentially ‘fake news’ and misleading to the medical and scientific community.
Although listed authors are accountable for all aspects of the work, they are generally known as key opinion leaders or KOLs — influential researchers and physicians selected by the commercial entity to participate in the study. Some KOLs are academics who may have authored hundreds of publications. Others are busy clinicians with less requirement or interest in publishing. Once the study is completed, decisions are made by relevant stakeholders to publish the findings, and a freelance or professional writer is engaged to work directly with the KOLs to create a submission-ready manuscript.
The criteria of accountability can easily be lost when a freelancer drafts a manuscript reporting on data that she has obtained from an external source. For example, a study may be commissioned by Acme Pharmaceuticals, who has selected certain KOLs to lead the study, and has engaged the services of Emca Data Systems to collect and curate their data. This data may then be analysed by Roadrunner Analytics, which provides summaries and study estimates that are given to the professional writer, Ms Kayotte, who liaises with the KOLs to draft the manuscript.
Who then is accountable for the accuracy of the published findings? Ms. Kayotte may assume that it is not her responsibility to do any accuracy checks and that what she got from Roadrunner Analytics was ready to be written up. When none of the previous entities are transparent in this process, or named in the final publication, and reputation, time frames, and costs are a primary concern, it becomes incredibly easy for matters of accuracy and accountability to be lost in this complex mix of players, protocols and data confidentiality concerns. The real question that relates to GPP3 guidelines, as well as those developed by Medicines Australia, is who ultimately is responsible for the integrity and accuracy of what is published?
As in the above scenario, a freelancer may be commissioned to write a manuscript for a client, and a preliminary analysis may be provided for review. As many of us who work with data know, the process of exporting data from one format to another can often introduce errors. It is simply fundamental to anyone involved in or with data analysis, that it never be assumed that the first round of analysis is ready for write-up. In the above scenario, the freelancer unfortunately makes this assumption!
It must be stated that it is simply a matter of good ethics in science to do multiple data integrity and accuracy checks. It is advisable to have someone else on your team independently review the manuscript, even at the submission stage, to ensure that your publication will stand up to scrutiny, and hand on heart, you can attest to its accuracy.
If after publishing a manuscript, errors are discovered, the ethical thing to do is submit a corrigendum or erratum to the journal. This serves not only to attest to your integrity as a scientist, but acknowledges that errors can be discovered even after publication. Before proceeding with the analysis, it is advisable to do some preliminary checks on the exported data, i.e. are the demographics of the study population what you are expecting? These data checks can be done very quickly by those intimately involved in the study protocol. But as an author would know, you never assume a preliminary analysis is final, NEVER!!
The important question for those who hire freelancers is, are your freelancers as concerned about the quality, clarity and accuracy of manuscripts reporting your important proprietary data, as an author would be? When it comes to work that really matters, it is important to employ professional writers with a long publishing history, and who have high ethical standards that are reflected in the manuscripts they are responsible for.
I have written previously on the challenges of reproducible research, as this continues to generate much discussion in the academic scientific community. Given the complicated process of getting the data to the stage where a manuscript is drafted, it is essential the writer liaise with the authors and KOLs involved in commercial research to verify the accuracy of the reported data.
Clearly there is a considerable difference in expectation and responsibility attributed to authorship vs freelance medical writers. However, it should be emphasized that, for the sake of her reputation, the professional writer who puts ‘pen to paper’ (fingers to keyboard) to draft the manuscript, needs to take full responsibility for ensuring that what she is writing is an accurate representation of the data. It should be a part of her role to conduct data checks and insist that this is non-negotiable in a scientific environment that is plagued by retractions, even if the manuscript is held up in order to ensure its integrity.
The value of working with professional writers who have sufficient experience as authors, and who also have expertise with data analysis cannot be overemphasized. Writers should at the very least be aware that several rounds of data checks are necessary before you enter the submission process. In other words, before you hire a freelancer or contract with an agency, check them out on PubMed to see if they have actually published anything, and when. Junior scientists employed by medical communications agencies, and freelancers with little or no actual experience writing up their own work for publication, will not appreciate the nuances of data manipulation and the importance of data accuracy, nor will they have sufficient experience as novices to understand the implications of publishing incorrect data.
“Properly trained and experienced writers can help authors with the development of publications in a compliant, complete, and timely manner, particularly when authors have limited time… Professional medical writers have a responsibility to ensure that findings are presented clearly, accurately, and without any intent of misleading readers.” (Battisti et al 2015, GPP3)
Additionally, freelancers are under the same requirement to observe ethical practices as do authors, and should do their due diligence to ensure that the data they are reporting on is indeed accurate, and sufficient data checks have been done by those commissioned to do so, before drafting the manuscript.
By ensuring data accuracy, you avoid the inevitable disappointments and frustrations that are incurred when a manuscript is withdrawn or held up because the manuscript was drafted on the basis of a preliminary analysis.
At SugarApple Communications our writers are also long-standing authors with experience in all stages of the publication process, including data management, statistical analysis, and ethical publication practice. We will liaise with all stakeholders to ensure that analyses are accurate and correctly interpreted, and follow it through to the final publication stages. Don’t risk putting your important research in the hands of multiple entities, or novices with no actual authorship experience, when your costly efforts matter!
We can help you find the best way to communicate with your intended audience and assist with writing, editing and statistics. Get in touch today and let’s talk.