Medical communicators and publications share a serious responsibility for advancing scientific knowledge and following ethical practices and guidelines.
A number of organizations have released position statements, guidelines, and best practices that can be useful when navigating ethical concerns in scientific publishing.
When medical communicators understand and internalize these standards of integrity and transparency, they can help balance the expectations of stakeholders and publish material that meets the highest ethical standards.
Where do medical communicators find ethical guidance?
The AMWA Code of Ethics
AMWA members adhere to a set of principles that define the roles of medical communicators. These principles apply to all professional conduct. According to the Preamble of the AMWA Code of Ethics, “These principles take into account the important role of medical communicators in writing, editing, and developing materials in various media and the potential of the products of their efforts to inform, educate, and influence audiences.”
All 8 principles can be applied to working with scientific publications; however, several principles are particularly salient when working with scientific publications.
Principle 1. Medical communicators should recognize and observe statutes and regulations pertaining to the materials they write, edit, or otherwise develop.
Principle 2. Medical communicators should apply objectivity, scientific accuracy and rigor, and fair balance while conveying pertinent information in all media.
Principal 4. Medical communicators should work only under conditions or terms that allow proper application of their judgment and skills. They should refuse to participate in assignments that require unethical or questionable practices.
What are some of the resources medical communicators can use to ensure they are following ethical principles?
AMWA-EMWA-ISMPP Joint Position Statement
In order to align international ethical principles, AMWA, the European Medical Writers Association (EMWA), and the International Society for Medical Publication Professionals (ISMPP) have published a Joint Position Statement on the Role of Professional Medical Writers. This brief document outlines the responsibilities of professional medical writers and the responsibilities of authors who collaborate with professional medical writers.
Medical Writer Responsibilities
Professional medical writers help authors and sponsors follow guidelines for publishing research in an “ethical, accurate, and timely manner.” The Joint Position Statement declares that medical writers must
-
follow Good Publication Practice (GPP3) Guidelines and the recommendations of the International Committee of Medical Journal Editors (ICMJE),
-
consult the Consolidated Standards of Reporting Trials (CONSORT) statement, which establishes the standard for how authors report the results of randomized controlled trials, and
-
keep up to date with advances in ethics and best practices and make sure that authors and sponsors are aware of their obligations.
Author Responsibilities
Authors collaborating with professional medical writers need to provide input throughout content development and acknowledge the support of professional medical writers. Authors also are responsible for making sure the final text reflects the views of and is approved by all of the authors. If a medical writer meets the ICMJE criteria for authorship, they should be recognized as a co-author.
ICMJE Recommendations
The most comprehensive ethical guidance on scientific publications comes from the ICMJE, which continually updates its Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. The recommendations apply to ICMJE member journals, and nonmember journals have also adopted them.
Some of the highlights of this comprehensive document include
-
Clarification of the roles and responsibilities of authors, contributors, reviewers, editors, publishers, and owners
-
Guidance on authorship and non-author contributors
-
Discussion of artificial intelligence (AI) in scientific publications
-
A review of peer review responsibilities
-
A discussion of predatory publishers or pseudo-journals
-
Specifics on editorial issues, scientific misconduct, copyright, and overlapping submissions
-
Details on preparing and submitting manuscripts to journals
What Is Ghostwriting, and Is It an Ethical Practice?
When someone contributes substantially to a medical publication but is not acknowledged for their contribution, they are considered a ghostwriter. Professional medical writers are not ghostwriters, and AMWA and other professional associations strongly discourage ghostwriting, advocating for transparency and proper credit when professional medical writers are involved in the writing and publication process.
“Ghostwriting Prevalence Among AMWA and EMWA Members (2005 to 2014),” an article in the AMWA Journal by Cindy W. Hamilton, PharmD, ELS, and Adam Jacobs, PhD, explores the results of a survey documenting the practice of ghostwriting, which the survey defines as “undisclosed substantial contributions by medical writers.”
The authors reported a significant (44%) drop in the number of manuscripts with undisclosed contributions between 2005 and 2014. They noted this positive trend, but as the authors state, “the 34% rate of ghostwriting remains unacceptable.” The survey was limited to AMWA and EMWA members, so it may not reflect the overall level of ghostwriting. However, it created the impetus for collaborative efforts to create and share best practices for acknowledging the contributions of professional medical writers, who often play significant roles in writing and preparing manuscripts.
“Without transparency, readers are denied the opportunity to judge the potential influence by groups with special interests and other conflicts,” the authors write. “Allegations of bias and other transgressions have a domino-like effect and tarnish not only the reputations of medical communicators but also the entire profession of medical communication as well as their sponsors.”
The responsibilities of medical writers should not be undertaken in the shadows, and ghostwriting violates the principles of transparency spelled out in most of the guidance on medical publications.
Authorship Ethics
One prevailing ethical question for professional medical communicators is whether their contributions meet the standards for authorship. There is no cut-and-dried answer; it depends on the level of the writer’s involvement.
The standards for determining authorship exist in the ICMJE Guidelines.
The ‘Who Is an Author?’ section of the guidelines recommends the following 4 criteria for 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.”
Contributors who meet all of these criteria should be identified as authors. If they don’t meet the criteria for authorship, they should be acknowledged as non-author contributors.
The Ethics of Artificial Intelligence
Another ethical question that arises frequently is connected to the increased use of artificial intelligence (AI) in the medical and pharmaceutical industries. Certainly, AI is being used to enhance the work of medical communicators, but it cannot be a medical writer, nor can it be an author. It does not meet the ICMJE criteria for authorship because it is not capable of being accountable for the content of a document.
The Changing Landscape
As medicine and technology change, so do the ethics of communicating about these important issues. As the AMWA Code of Ethics states, medical communicators are responsible for keeping up with “advances in ethics and best practices.”
Networking with colleagues and attending events and conferences where these issues are discussed is a critical way to stay in touch with evolving issues such as determining authorship, the ethical use of AI, and other topics that engage and animate this dynamic profession.
AMWA acknowledges the contributions of Nadine Odo, MPH, CCRC, ELS, FACRP, for peer review in the development of this AMWA resource.
