Three Essential Ethical Guidelines Every Medical Writer in Publication Planning Should Know (pubs ethics perspective 2)
A practical introduction to publication ethics, transparency, and responsible scientific communication
Written By: Nicole Bowens, PhD
Medical writing is often introduced as a discipline focused on clarity, structure, and translating complex science into readable form. In practice, however, ethical considerations shape how information is presented, how credit is assigned, and how disclosures are handled throughout the publication process. For medical writers involved in publication planning, understanding these expectations is essential, as they directly influence day-to-day decisions and determine whether a manuscript meets professional standards. This article outlines three key ethical principles that should guide medical writing work in publications planning.
Research/Evidence
Publication planning is guided by established ethical frameworks that define how scientific information is developed, attributed, and reported. Good Publication Practice 3 (GPP3) is one of the most widely used frameworks in industry-sponsored publication development. It outlines expectations for authorship criteria, disclosure of contributions, and publication process documentation.
Authorship Criteria
Essential guideline 1: Authorship should be based on meaningful intellectual contributions, with all listed authors meeting established criteria and taking responsibility for the integrity of the work.
Authorship decisions should be established early in the publication planning process, with clearly defined roles that distinguish authors from contributors. Authorship is reserved for individuals who meet established criteria based on intellectual input, while those who contribute to manuscript development without meeting these criteria are not listed as authors.
In practice, medical writers are typically not included as authors unless they contribute to the intellectual interpretation of the data and participate in substantive decisions that shape the manuscript. When their role is limited to drafting, editing, and coordinating content, their contribution is reflected in acknowledgments rather than authorship.
Medical writers often work with multiple authors who provide input, feedback, and revisions at different stages of development. This requires managing iterative comments from different contributors, reconciling potentially conflicting feedback, and maintaining consistency across versions while ensuring the manuscript remains aligned with the underlying data and the agreed-upon scientific direction of the author group.
Disclosure of Contributions
Essential guideline 2: All contributions, funding sources, and potential conflicts of interest should be clearly disclosed so readers can evaluate the context of the research.
GPP3 emphasizes that publications should clearly identify who contributed to the work, who funded the research, and whether any relationships exist that could influence the design, conduct, or interpretation of the study. These disclosures are typically captured in dedicated sections of the manuscript and are intended to provide transparency around the conditions under which the work was developed.
In practice, medical writers play a coordinating role in gathering and organizing this information from all contributors. This includes ensuring that funding details, author declarations, and conflict of interest statements are complete, consistent, and aligned across the document. Because contributors may provide disclosures at different times or in different formats, the medical writer often needs to reconcile discrepancies and confirm that all required information is accurately reflected in the final publication.
Publication Process Documentation
Essential guideline 3: Each contributor’s role should be defined and documented throughout the process to ensure accountability, traceability, and consistency in the development of the publication.
GPP3 highlights the importance of maintaining clear records of how a publication is developed, including documentation of author contributions, review cycles, version history, and approvals. This creates a transparent record of the decision-making process and supports accountability among all contributors.
In practice, medical writers are often responsible for maintaining or coordinating this documentation across multiple stages of manuscript development. This includes tracking revisions, consolidating feedback from different authors, recording approvals, and ensuring that the final version reflects agreed-upon changes. Because manuscripts typically evolve through several rounds of input, accurate documentation helps preserve a clear audit trail of how the content was shaped and provides assurance that the process aligns with established publication standards.
Personal Perspective
Taken together, these elements reflect how GPP3 operates in real publication work, shaping decisions around authorship, disclosures, and documentation throughout the development process.
From my perspective, one of the more demanding aspects of medical writing is coordinating across multiple authors who may have different expectations, levels of involvement, and timelines. Feedback often arrives at different stages and can sometimes conflict, so part of the role involves reconciling input, clarifying requested changes, and maintaining consistency while keeping the manuscript aligned with the data and the agreed direction.
In practice, this work often requires skills that go beyond writing, including project management and conflict resolution. Managing deadlines across multiple contributors, handling delays or drop-off in engagement, and navigating differences of opinion within an author group are common situations that need to be addressed to keep a project moving forward. These responsibilities are a regular part of the process and become more manageable with experience working in collaborative publication environments.
Additionally, ethical guidelines regarding AI use are currently being formalized by professional organizations in publication planning such as the COPE (Committee on Publication Ethics). Both current and aspiring publication planning professionals will need to stay abreast of these new developments.
Key Takeaways
Authorship should be determined by meaningful intellectual contributions, with clear distinction between authors and contributors, and early agreement on roles within the author group.
All funding sources, contributor roles, and potential conflicts of interest should be fully disclosed so readers can understand the context in which the work was developed.
Each contributor’s role should be documented throughout the publication process, with clear records of contributions, revisions, and approvals to support transparency, accountability, and consistency.
Guidelines regulating AI use are evolving, and it will be essential to stay up to date on official statements from professional organizations.
Other Voices on This Topic
Consider reading these additional articles for unique perspectives and advice.
A beginner’s guide to authorship, transparency, and data integrity
References
Evuarherhe O, Gattrell W, White R, Winchester CC. Professional medical writing support and the quality, ethics and timeliness of clinical trial reporting: a systematic review. Res Integr Peer Rev. 2019;4:10.
Mills I, Sheard C, Hays M, Douglas K, Winchester CC, Gattrell WT. Professional medical writing support and the reporting quality of randomized controlled trial abstracts among high-impact general medical journals. F1000Research. 2017;6:13720.
Battisti WP, Wager E, Baltzer L, et al. Good publication practice for communicating company-sponsored medical research: GPP3. Ann Intern Med. 2015;163(6):461-464. Guideline (ISMPP)
International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. Updated January 2026.
AI Disclaimer
ChatGPT and Gemini AI were used to research, draft, and edit this article.
Contributions of Blog Creator
Nicole Bowens, PhD, created this blog to bring together perspectives from medical writers at all experience levels, with the goal of supporting those who are aspiring or early in their careers.
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Writer: Nicole Bowens, PhD
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