The writers' associations' guidelines and position statements
The writers' associations set out what they ask of professional medical writers in guidelines and position statements. EMWA has published guidelines on the role of medical writers in publications, and AMWA and EMWA have each published a statement on ghostwriting. AMWA, EMWA and the International Society for Medical Publication Professionals wrote a joint position statement together, which sets out what professional medical writers, and the authors who work with them, must do when developing publications, and which has since been translated and taken up beyond the three bodies.
Guidelines and position statements on ghostwriting
EMWA's 2005 ethical guidelines on the role of medical writers in developing peer-reviewed publications were written for writers who prepare manuscripts on behalf of named authors, in part to help address ghost authorship. They cover the relationship between the writer, the study sponsor and the authors; whether writers should be listed as authors and, if not, how they should be acknowledged; the writer's professional and ethical responsibilities; and the writer's access to study data.
Both AMWA and EMWA have published position statements on ghostwriting, and the EMWA statement includes involving the named authors early in the publication process, refusing requests to develop publications without sufficient involvement of the named authors, and refusing requests to develop publications in an unethical or irresponsible manner.
EMWA's position statement on ghostwriting distinguishes ghostwriting, which it calls unethical, from professional medical writing assistance, which it calls legitimate and desirable. It defines ghostwriting as what happens when someone writes a paper for publication in the medical literature and neither the identity of the writer nor the funding source of the writing is disclosed to the reader. EMWA's guidelines, by contrast, state that the contribution of medical writers and their funding source should be made explicit. The statement adds that a writer who does not meet a journal's authorship criteria, and so cannot be listed as an author, must be listed in an acknowledgements section to avoid ghostwriting. EMWA published the statement in March 2013, after a popular science book had described it as a ghostwriters' association, to make clear that it is an association for professional medical writers that deplores ghostwriting and that its guidelines treat ghostwriting as unacceptable. The statement also commits EMWA to continuing efforts to eradicate ghostwriting from the medical literature, and invites constructive suggestions for doing so more effectively.
What the joint statement covers
The AMWA–EMWA–ISMPP Joint Position Statement on the Role of Professional Medical Writers describes the appropriate role of professional medical writers in developing medical and scientific publications: articles and supplementary content, such as video abstracts, for peer-reviewed journals, and abstracts, posters and oral presentations for scientific congresses. It sets out ethical standards for medical writers who help to develop scientific and medical publications. It explains the value of professional medical writing to evidence-based medicine by summarising the current evidence on the writer's role in the ethical, accurate and timely disclosure of research results in publications, abstracts, posters and oral presentations. It states that it is in line with up-to-date guidelines from several other international organisations.
The statement builds on the Good Publication Practice (GPP3) guidelines and the recommendations of the International Committee of Medical Journal Editors (ICMJE), describes best practices for professional medical writers, and provides a template for disclosing medical writing support. AMWA's announcement of it says that it supplements the association's own statements on ethical publication practices, including its Code of Ethics and its Position Statement on the Contributions of Medical Writers to Scientific Publications. AMWA's past president Art Gertel said that it describes, for the first time, a global standard for professional medical writers, and that it will serve as a valuable reference for ethical publication practices worldwide.
What the joint statement asks of writers
The statement holds that professional medical writing support helps authors and sponsors disclose their research in peer-reviewed journals and at scientific congresses in an ethical, accurate and timely manner, with the ultimate aim of advancing patient care, and that professional medical writers have extensive knowledge of ethical publication guidelines. It requires writers who assist authors in communicating the results of company-sponsored research to:
- follow the GPP3 guidelines and the ICMJE recommendations
- consult appropriate reporting guidelines, such as CONSORT and the others collated by the EQUATOR Network
- ensure that the authors and sponsors are aware of their obligations under those guidelines
- keep up to date with advances in medical communications ethics and best practice.
What the joint statement asks of authors
The statement requires authors who choose to collaborate with a professional medical writer on manuscripts or congress presentations to:
- ensure that they have access to all relevant information, such as protocols, statistical analysis plans, statistical analyses and clinical study reports
- provide intellectual input before writing commences and throughout content development
- ensure that the final text fully reflects the views of, and is approved by, all authors
- affirm the appropriateness of the final choice of journal or congress
- acknowledge the writing support, naming the nature of the support, the name, highest relevant qualification and affiliation of the writer accountable for it, and the funding sources for it
- recognise as a co-author any contributor, the professional writer included, who meets the ICMJE authorship criteria.
How the joint statement came about
AMWA, EMWA and the International Society for Medical Publication Professionals released the statement on 17 January 2017, the first unified position of the three organisations on the role of professional medical writers. It began when EMWA's Executive Committee identified the need to update EMWA's guidelines on medical writing and a joint position statement endorsed by both AMWA and EMWA was proposed. The International Society for Medical Publication Professionals then joined, and eight months after the proposal the statement was launched at the society's 2017 European meeting in London.
The organisations' existing guidance dated back five years or more, and the new statement took account of updated guidelines from professional bodies around the world and cited new evidence about medical writers' understanding of best-practice guidelines and about the profession's value to evidence-based medicine. It also united three organisations with a combined membership of over 6,500, collaborating for the first time, to fill an unmet need to speak with one voice for medical writers and communicators around the world.
Four senior representatives formed its writing committee: Art Gertel for AMWA, Chris Winchester for EMWA, and Karen Woolley and Yvonne Yarker for ISMPP. Representatives of the three organisations in Europe, North America and Asia drafted and reviewed it. Its EMWA author states that it supersedes the participating organisations' previous position statements and guidelines. Its ISMPP co-author describes the result as a unified, concise and evidence-based statement of clear, practical guidance for medical writing and publication professionals around the globe. It was to be presented at the 2017 EMWA Congress in Birmingham, in a special lunchtime session and, earlier the same day, in an Expert Seminar Series titled "Improving quality and maximising value: professional medical writers and peer-reviewed publications".
Translations and endorsements
By September 2018 the statement had been translated into two new languages, Russian and Farsi, which EMWA counted an important step towards further raising awareness of the role of professional medical writers. EMWA was involved in translating it, to spread the word among non-native English speakers in Europe and beyond. By autumn 2018 it had been translated into 10 languages.
In the months before March 2019 the statement received various organisational endorsements, was the subject of journal articles and was translated into new languages, activity EMWA took as a testament to the longevity of, and continued interest in, its principles. In September 2019 EMWA was still translating it for non-native English speakers in Europe and beyond. By then it was available on EMWA's website in French, German, Italian, Spanish, Romanian, Portuguese, Hungarian, Ukrainian, Russian, Farsi and Greek, and a member had newly translated it into Hebrew. In March 2020 EMWA was still organising translations of it, which it said help to spread awareness among non-English speakers of the responsibilities of medical writers.
Bodies that have endorsed or recognised it include the EQUATOR Network, the European Association of Science Editors, the Council of Science Editors, the Board of Editors in the Life Sciences, the Association of Regulatory and Clinical Scientists in Australia and the Australasian Medical Writers Association.