AMWA acknowledges the contributions of Crystal Herron PHD, ELS, as lead content developer, and Michelle Sauer Gehring PHD, ELS, for peer review, in the development of this AMWA resource.
As the world moves in a more interconnected, digital, and collaborative direction, best practices in authorship have become less straightforward.
Medical writers may find themselves contributing to manuscripts in many ways and might encounter problematic examples of ghost authorship, gift authorship, and guest authorship.
The dramatic increase in the use of artificial intelligence (AI) has further complicated questions of authorship, leading to updates in the guidelines most journals use to determine whether someone is an author or a non-author contributor.
What are the current standard practices for determining authorship? Why do editorial and scientific organizations discourage the practices of ghost, gift, and guest authorship? Where do we find clear and transparent guidance for professional medical writers whose contributions should be acknowledged?
A Matter of Ethics
The prestige of authorship comes with ethical responsibility. Anyone listed as an author on the byline—including medical writers—promises to stand behind all the information that is included in the publication.
AMWA’s Code of Ethics includes a number of principles that apply to authorship. For example, one principle states that medical communicators should apply objectivity, scientific accuracy and rigor, and fair balance while conveying pertinent information in all media.
Another relevant principle states that medical communicators should write, edit, or participate in the development of information that meets the highest professional standards, whether or not such materials come under the purview of any regulatory agency. They should try to prevent the perpetuation of incorrect information. Medical communicators should accept assignments only when working in collaboration with a qualified specialist in the area, or when they are adequately prepared to undertake the assignments by training, experience, or ongoing study.
When medical communicators follow these ethical standards regarding authorship and other key aspects of the work, they help bolster the reputation of the profession and protect scientific integrity.
Determining Authorship
The gold standard for identifying who qualifies for authorship of a scientific manuscript is found in the recommendations published by the International Committee of Medical Journal Editors (ICMJE).
The ICMJE guidelines are crafted for authors who submit work for publication in ICMJE member journals; however, many non-ICMJE journals also have adopted similar guidelines.
In addition to clarifying the criteria for authorship, the ICMJE guidelines outline the roles and responsibilities of authors, contributors, reviewers, editors, publishers, and owners.
ICMJE Criteria for Authorship
In the ‘Who Is an Author?’ section of the guidelines, the ICMJE recommends the following 4 criteria for being named an author. All 4 criteria must be met to determine authorship.
- “Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
- Drafting the work or reviewing 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.”
This article in AJE puts it simply: “Could you stand up and give a talk (and answer questions) about the research project in question? If not, then you shouldn’t be an author on the publication.”
Although good standards, such as ICMJE’s, exist to help determine authorship, sometimes the situation is not clear.
In most cases, medical writers will need to use their best judgment, discuss the situation with contributors, and review the manuscript submission guidelines to determine authorship.
How to Acknowledge Non-author Contributors
People who acquire funding, supervise a research group, or assist with writing, technical editing, language editing, and proofreading are all considered non-author contributors. Even though they are not authors, their contributions are significant and should be acknowledged.
The ICMJE recommends obtaining written permission from the individuals who are acknowledged. Such contributions can be listed under the heading “Clinical Investigators” or “Participating Investigators.” Individuals should be named specifically. For example,
- “XX served as scientific advisors…”
- “XX critically reviewed the study proposal…”
- “XX collected data…”
- “XX provided and cared for study patients.”
- “XX participated in writing or technical editing of the manuscript.”
Professional medical writers are often credited using the language in the final bullet point above.
Acknowledging Professional Medical Writers
The involvement of professional medical writers in manuscript writing and preparation improves the quality of the writing and enhances scientific communication. If proper codes of ethics and guidelines are followed, no controversy need arise regarding this relationship.
Crediting someone who contributes substantially to a document is both an ethical and a professional matter. Over the decades, a number of significant discussions and articles have appeared in the AMWA Journal addressing questions and issues regarding authorship.
In particular, it is important to recognize potentially problematic or unethical authorship practices, including the use of artificial intelligence (AI), ghost, guest, and gift authorship.
Ghost Authorship
Ghost authorship (or anonymous authorship) is a common practice in the literary world. Think of the books published by celebrities or politicians. In the scientific world, ghost authorship refers to anyone who contributes to a work but is not credited. Examples of unethical ghost authorship include
- An academic researcher hires a company or individual to write a manuscript or dissertation and fails to acknowledge them for their role.
- A pharmaceutical company sponsors a clinical trial and hires a medical communication agency to assist with the generation of the manuscript from the clinical study report. The scientists involved with the study are listed as authors but do not meet the ICMJE requirements for authorship.
- Any researcher or medical communicator who assists with the manuscripts and meets all the ICMJE criteria for authorship but is not listed on the author byline.
An article by José Florencio F. Lapeña, Jr. in the Philippine Journal of Otolaryngology Head and Neck Surgery explores some extreme examples of ghost (as well as gift and guest authorship). The author mentions term paper and dissertation establishments operating in Manila and a University of Wisconsin professor who ghost-authored an article on a diet pill called Redux; the pill was later linked to dozens of deaths. Because firms and medical writers that have unethical practices have produced favorable articles about drugs, and doctors and pharmacists have signed their names to the works, it is imperative that the field strongly condemn these actions. Ghost authorship in medical writing is not acceptable.
More resources on ghostwriting are available here.
Guest and Gift Authorship
Guest authorship occurs when high-profile figures are added to a list of authors despite not having direct involvement in completing the research. “A student or resident may knowingly invite an advisor or consultant to be listed as co-author, even if the latter did not meet authorship criteria,” writes Lapeña. A student may think that adding a recognized person as a guest author could increase the chance of publication, but in fact they are risking their own reputation because guest authorship is unacceptable in the scientific community.
To be clear, advisors sometimes do meet the criteria for ICMJE authorship, but granting guest authorship is a different matter. Guest authorship does not align with ICMJE standards or the AMWA Code of Ethics. When a medical editor or writer sees this practice taking place, they have a responsibility to advise the team on established authorship guidelines.
Similarly, gift authorship, or honorific authorship, occurs when someone is credited as being an author when they do not meet ICMJE criteria for authorship. This could be a junior researcher trying to credit a supervisor’s contribution or an authorship gifted to a junior researcher to help boost their career.
Gift authorship is unacceptable and unethical in medical writing and does not meet ICMJE standards for authorship.
The Role of Medical Writers in Publications
To clarify the role of professional medical writers, AMWA worked with the European Medical Writers Association (EMWA) and the International Society for Medical Publishing Professionals (ISMPP) to create a joint statement on the role of professional medical writers. This statement outlines the responsibilities of professional medical writers who support authors and sponsors of research/manuscripts. It also outlines the responsibilities of authors who collaborate with professional medical writers.
Responsibilities of Professional Medical Writers
In brief, the position statement asserts that professional medical writers must adhere to Good Publication Practice (GPP) guidelines and the ICMJE recommendations. They should also consult reporting guidelines, such as CONSORT, and others collated by the EQUATOR network. They need to ensure that authors and sponsors are aware of their responsibilities to the guidelines and stay up to date with advances in medical communication ethics and best practices.
Author Responsibilities
Authors who collaborate with professional medical writers need to ensure they have access to all the relevant information, such as protocols, statistical analyses, plans, and clinical study reports. They also need to provide input before and during the writing process. They need to guarantee that the final text—and the choice of journal or congress—reflects the views of the authors and is approved by all authors. Finally, they need to acknowledge the support of professional medical writers, including the highest relevant qualifications or credentials, affiliation, and funding support. All contributors who meet the ICMJE authorship criteria need to be recognized as co-authors.
Non-human ‘Authors’
In addition to sorting out the question of authorship among human contributors, the increased reliance on chatbot AI in many industries has led a number of scientific journals and organizations to revise their guidelines to address the use of AI in medical writing.
In May 2023, the ICMJE updated its “Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals” to include a section on Artificial Intelligence (AI)-Assisted Technology.
It reads: “At submission, the journal should require authors to disclose whether they used artificial intelligence (AI)-assisted technologies (such as Large Language Models [LLMs], chatbots, or image creators) in the production of submitted work.”
The journal Nature has clarified that tools such as chatbots cannot be credited as authors because “attribution of authorship carries with it accountability for the work, and AI tools cannot take such responsibility.”
The Journal of the American Medical Association (JAMA) and JAMA Network have also changed Instructions for Authors to include the following wording: “Nonhuman artificial intelligence, language models, machine learning, or similar technologies do not qualify for authorship.”
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