Ethical Considerations for Medical Writers: A Summary

Spanning 240 pages, chapter 5 of the AMA Manual of Style underscores the complexity and importance of ethical considerations in medical writing. Below, we review the guidance it provides on topics such as authorship responsibilities, acknowledgements, conflicts of interest, intellectual property, confidentiality, and the importance and tenets of editorial freedom.

Authorship for Scientific Articles

Defining authorship is more nuanced than many realize. To be considered an author of a scientific article, an individual must:

  • Significantly participate in designing the study
  • Contribute to data acquisition and analysis
  • Draft and revise the manuscript
  • Approve the final draft
  • Agree to be accountable for the work’s integrity

The standards are intentionally high to ensure that those listed as authors have made meaningful, substantive contributions to the research without which the work could not have been completed. Simply securing funding, supervising administrative tasks, or performing basic writing and proofreading does not qualify someone for authorship. Guest authors, including supervisors and department chairs, and ghost authors are not permitted as authors.

Each manuscript submission requires a corresponding author who handles all communications about the paper. The first author should be the individual who made the largest contribution to the work; authors themselves determine the order of listed authors.

Acknowledgements

The acknowledgment section recognizes contributions that do not meet full authorship criteria. These sections list grant and funding support, donors, technical assistance, and other contributions from individuals who do not qualify as authors, such as medical writers. They also allow for the recognition of collaborators—members of the formal research group who made significant contributions but do not meet the full criteria for authorship.  Importantly, written permission must be obtained from each individual mentioned in this section.

Beyond crediting contributors, the acknowledgment section serves as a transparency mechanism. Authors must disclose any conflicts of interest and report the use of AI language models in the writing process. Additionally, authors are required to detail the specific role of each sponsor and funding source, explaining their involvement across all stages of the research—from initial study design and data collection to analysis, manuscript preparation, review, and final publication submission.

Manuscript Submission

Upon submitting a scientific paper for consideration of publication, authors must establish a publishing agreement with the prospective journal, in which they disclose any conflicts of interest, identify funding sources, develop a data-sharing plan, and ensure that at least one author has full access to all data.

Researchers must disclose any duplicate publications to prevent data inflation and unintended redundancy. This includes situations where the same data appear in multiple studies or are submitted to multiple journals, which can lead to double-counting of research findings in systematic reviews.

Conflicts of Interest

Conflicts of interest arise when financial or personal relationships could bias an author’s or editor’s professional judgment. Authors and editors must disclose all potential conflicts of interest—both actual and perceived—including relationships formed during manuscript preparation and the three years preceding it. This transparency requirement extends beyond research papers to include opinion pieces, editorials, and the peer review processes. When a conflict of interest exists, editors must recuse themselves from reviewing or making decisions about related manuscripts.

Scientific Integrity and Misconduct

Scientific misconduct represents a serious breach of academic trust. It includes misappropriation, misrepresentation, fabrication, falsification, plagiarism, breaches in confidentiality, omission of data, and inappropriate manipulation of digital images. However, it does not include honest error or differences in opinion.

When errors are discovered that require retraction of a publication, the process must be handled with utmost transparency. Retraction notices should provide a complete citation to the original article, clearly state the reason for retraction, and ideally be presented as a signed letter from the original authors. These notices must be freely accessible so that the scientific community can track and understand the reasons behind publication withdrawal.

Intellectual Property and Data Sharing

The landscape of scientific data is increasingly moving towards openness and accessibility. Ideally, researchers should make data as widely and freely available as possible, while also safeguarding participant privacy and protecting confidential and proprietary information.

With the exception of commercially owned data, scientific information is generally considered a public good, with ownership typically residing with governments and institutions rather than individuals. This promotes global collaboration and knowledge sharing while protecting the interests of researchers and participants.

While open access publishing has significantly advanced research transparency and global knowledge exchange, it has also given rise to predatory journals, which charge authors to publish without implementing rigorous peer review or editorial standards.

Confidentiality in Research

Confidentiality occurs when person discloses information to another with the understanding that the information will not be divulged to others without permission.

Protecting research participants is paramount to ethical scientific research. Every study involving human participants must undergo independent ethics review, ensuring that the study’s nature, purpose, and potential risks are fully disclosed. Informed consent is a fundamental requirement that respects participants’ autonomy and safety.

Authors must be meticulous about protecting participant identities, either by removing identifying information or by obtaining explicit consent from patients for its use. This ensure both participant safety and the research’s scientific integrity.

The principle of confidentiality extends beyond research participants to the scientific publication process itself. Authors must be assured that when submitting manuscripts, their proprietary work and unique ideas will remain protected from unauthorized distribution.

Editorial Freedom

Editorial freedom ensures that editors to make decisions independently, free from external interference. To uphold this autonomy, editors must possess full authority over editorial content, without pressure from stakeholders including owners, publishers, advertisers, sponsors, authors, reviewers, and readers.

The responsibilities of an editor extend far beyond content selection. Editors must inform and educate readers while maintaining the journal’s quality and integrity. A competent editor must identify and remove linguistic manipulation such as bias, hyperbole, inconsistent arguments, and unsupported assertions from manuscripts.

Editors are also responsible for advertisements and sponsored material. While scholarly content aims for objectivity, advertisements inherently persuasive. Recognizing this conflict, journal editors must implement strict advertising guidelines to preserve editorial integrity.

Advertising content must meet high ethical standards. Every advertisement should present verifiable claims, provide comprehensive information, and avoid misrepresentation. Importantly, ads must transparently identify the product or service provider and be visually distinct from editorial content to ensure readers can easily differentiate between journalism and promotional material.

News Releases

The chapter concludes with recommendations for clear and responsible medical writing in news coverage of new research. Key reporting recommendations include:

  • Avoid sensationalist language such as “cure,” “miracle,” “breakthrough,” “promising,” “dramatic,” “hope,” and “victim.”
  • Ensure a clear understanding and correct use of statistical and mathematical terms.
  • Carefully distinguish between correlation and causation.
  • Avoid using “significant” without distinguishing between statistical and clinical significance.
  • Avoid confusion between absolute and relative risks.
  • Present risks and benefits with equal emphasis.

Conclusion

Navigating the ethical and legal landscape of medical writing requires diligence, integrity, transparency, and adherence to professional standards. By understanding and applying the principles outlined in Chapter 5 of the AMA Manual of Style, medical writers can contribute to the advancement of scientific knowledge while maintaining the highest levels of ethical conduct.


Reference:

AMA Manual of Style Committee. AMA Manual of Style: A Guide for Authors and Editors. 11th ed. Oxford University Press; 2020

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