Who Gets Credit? A Medical Writer’s Guide to ICMJE Compliance
Authorship in medical publications is more than just a byline—it’s a statement of contribution, accountability, and transparency. The International Committee of Medical Journal Editors (ICMJE) authorship guidelines help ensure that only those who genuinely contribute to research receive credit, while also preventing guest and ghost authorship, two practices that can undermine the credibility of industry-sponsored publications.
What Do the ICMJE Guidelines Say?
According to ICMJE, an author must meet all four criteria listed below. The individual has:
Made substantial contributions to study design, data collection, or data analysis/interpretation.
Drafted or critically revised the manuscript for intellectual content.
Provided final approval of the published version.
Is held accountable for all aspects of the work, ensuring accuracy and integrity.
This means that individuals who don’t meet all four criteria should instead be acknowledged for their contribution. In general, medical writers will not qualify for authorship. Importantly, large language models like ChatGPT cannot qualify for authorship because they cannot meet the fourth requirement.
Why It’s Important to Discuss This With Industry Sponsors
Clarifying Expectations Early: Misunderstandings about who qualifies for authorship can lead to delays, disputes, or ethical concerns. Medical writers should proactively discuss authorship requirements at the start of a project.
Ensuring Compliance: Many journals require authors to confirm ICMJE compliance, and regulatory bodies closely scrutinize industry-sponsored research.
Protecting Credibility: Ethical authorship reinforces transparency and trust, preventing reputational damage from improper authorship practices.
When to Discuss ICMJE Authorship With Sponsors
By proactively addressing authorship, medical writers help sponsors avoid ethical pitfalls, ensure compliance, and maintain trust in industry-sponsored research.
At the Project Kickoff or First Publication Meeting
Discuss authorship criteria before manuscript drafting begins to align expectations early.
Confirm who is responsible for study design, data analysis, and manuscript development.
Ask if a publication steering committee is in place to oversee authorship decisions.
Before Developing the First Draft
Ensure that all listed authors meet all four ICMJE criteria and are aware of their responsibilities.
Verify that medical writers are properly acknowledged rather than listed as authors.
During Manuscript Review and Revisions
Remind authors of their duty to review, approve, and be accountable for the content.
Ensure that substantial intellectual contributions are documented, especially if new contributors join later.
Before Journal Submission
Re-confirm that all authors meet ICMJE criteria and can sign the journal’s authorship declaration.
Address any last-minute authorship disputes to avoid submission delays.
How to Introduce the Conversation
Use a Checklist: Provide a simple ICMJE authorship checklist in the first meeting.
Ask Open-Ended Questions: “Who has made substantial contributions to study design and analysis?”
Reference Journal Policies: Many journals require ICMJE-compliant authorship declarations—use this as a conversation starter.
Frame It as a Best Practice: Position authorship discussions as part of industry compliance and scientific integrity, not just a journal requirement.
Medical writers play a key role in educating sponsors and ensuring compliance. By integrating authorship discussions early, we can support ethical, high-quality publications that uphold industry best practices.
Need help developing your publications? Acumen can help. We are experts in developing medical communications and navigating compliance with publications guidance. Reach out to discuss your upcoming projects.