10.2 Professional Medical Writing: Roles, Authorship, Disclosure & Funding

Professional Medical Writing: Roles, Authorship, Disclosure & Funding

Governing References

The AMWA-EMWA-ISMPP Joint Position Statement on the Role of Professional Medical Writers, released in 2017, is a current CMPP critical reference. Read it with GPP 2022, the current ICMJE Recommendations, the applicable reporting guideline, and the journal or congress instructions.

These sources have related but distinct roles:

What a Professional Writer May Do

A professional medical writer may help authors:

• plan an evidence-based outline;
• organize source documents and references;
• draft text from author-approved direction and validated analyses;
• apply CONSORT, SPIRIT, PRISMA, STROBE, or another relevant guideline;
• prepare tables, figures, plain-language material, abstracts, posters, or responses to reviewers;
• reconcile author comments;
• check consistency, terminology, citations, and data presentation;
• coordinate versions and approvals.

The writer must not invent data, make unapproved scientific decisions, conceal unfavorable results, add promotional claims, or submit without authorization. The author group remains responsible for the publication's scientific content and approval.

Author Responsibilities

The Joint Position Statement says authors working with a professional writer should:

1. have access to relevant information, such as protocols, SAPs, analyses, and clinical study reports;
2. provide intellectual input before drafting and throughout development;
3. ensure the final text reflects the views of all authors;
4. approve the final work;
5. affirm the appropriateness of the journal or congress;
6. acknowledge and fund-disclose writing support;
7. recognize as coauthors any contributors, including writers, who meet the authorship criteria.

A writer cannot replace author engagement. Sending a completed ghostwritten manuscript to academics for a superficial final signature is not a compliant process.

Authorship or Acknowledgment?

Professional writers are evaluated by the same authorship criteria as everyone else. Under ICMJE, all four criteria are required:

1. substantial contribution to conception/design or acquisition, analysis, or interpretation of data;
2. drafting or critical revision for important intellectual content;
3. final approval;
4. accountability for the work.

Drafting alone fulfills part of the second criterion, not all four. If a writer also makes a qualifying intellectual contribution, approves the final version, and accepts accountability, authorship should be considered. Employment by a sponsor or agency does not automatically disqualify the writer.

If the writer does not meet all four, disclose the support as a nonauthor contribution. Do not hide the person to avoid a perception of industry involvement.

Disclosure Elements

The 2017 Joint Position Statement recommends acknowledging:

• the nature of the writing or editorial support;
• the name of the professional writer accountable for that support;
• the writer's highest relevant qualification, such as a relevant degree or professional credential;
• the writer's affiliation;
• the funding source for the support.

This is “highest relevant qualification,” not every degree or a claim that credentials themselves prove competence. Follow the venue's exact disclosure placement and format. A sample can be adapted:

The authors thank [name, relevant qualification] of [affiliation] for [nature of support], funded by [funder].

If a journal requires the statement in acknowledgments, a contributor section, a funding statement, or a submission form, complete all required locations. An abstract's space limit does not justify anonymous support if the conference supplies a disclosure field.

Data Access and Final Data Check

Writers should receive the information necessary to draft accurately, subject to privacy and access controls. Named authors and individuals responsible for data integrity must be able to verify the work. GPP 2022's official FAQs explain that writers may supervise or perform quality control before the final data check, but named authors remain accountable and should perform the final check unless a writer is also a named author with the relevant responsibility.

Do not equate access to every row of identifiable participant data with responsible data access. Use validated tables, listings, reports, and controlled systems appropriate to the role.

Funding and Compensation

Separate four issues:

1. Who funds the research?
2. Who funds writing support?
3. Is an individual compensated for legitimate work?
4. Does that individual qualify for authorship?

All can require disclosure, but the answers are not interchangeable. GPP 2022 does not automatically bar compensation for legitimate publication work or steering-committee participation. Compensation should be reasonable, transparent, permitted by law and institutional or company policy, and clearly addressed in agreements. It must never purchase a byline, favorable opinion, prescribing influence, or suppression of inconvenient findings.

An author agreement may say there is no payment merely for being listed on the byline. That does not mean that every compensated writer, patient partner, consultant, or steering-committee member is ineligible for authorship. Apply the contribution criteria independently.

Workflow Controls

A compliant workflow includes:

• early contributor and author discussions;
• written roles, responsibilities, review expectations, compensation terms, and disclosure language;
• author-approved outline;
• version control and comment attribution;
• reconciliation to validated source data;
• documented author review;
• final data check by accountable authors;
• documented final approval;
• disclosure of contributions and funding;
• archive of the submitted and accepted versions.

If an author is unresponsive, follow the author agreement and venue policy. Do not silently convert the person from author to acknowledgment or acknowledge them without permission. Escalate the issue, document contact attempts, and seek editorial guidance where needed.

Applied Scenario

An agency writer drafts a manuscript from the protocol, SAP, clinical study report, and author-approved outline. The writer proposes no new analysis and does not take accountability for the whole work. The authors critically revise, verify the results, approve the final manuscript, and choose the journal. The appropriate outcome is transparent acknowledgment of the writer, relevant qualification and affiliation, the nature of support, and the funder.

If the same writer developed a novel analytical approach, interpreted the data substantially, critically revised the scientific content, approved the final work, and accepted accountability, the team should assess the writer against all four authorship criteria rather than excluding them because they are paid.