Acknowledging and disclosing a medical writer's contribution
A medical writer who is not an author is made visible on a publication through its acknowledgements and the disclosures that accompany its submission. Guidance asks that the writer, the service and its funder be named, and it extends to recording what every non-author contributed, but it leaves open how subcontracted writers are credited, and getting a client to acknowledge the writer can fall to the writer.
What the acknowledgement names
The ICMJE recommends listing every contributor who does not meet the criteria for authorship in an acknowledgements section, and those who might be acknowledged include a person who provided purely technical help or writing assistance, or a department chairperson who provided only general support. By 2009 journal editors had almost universally aligned themselves against the use of medical writers, particularly where their role was not acknowledged. By 2009 AMWA had called for written acknowledgement of a writer's involvement, in an attempt to address the ethical issues and bring the role of writers into the open, and many journals mandated the acknowledgement of writing assistance that the ICMJE recommends.
EMWA's guidelines recommend that the involvement of medical writers and their source of funding be acknowledged, and that the role of writers not listed among the authors or contributors be acknowledged explicitly. Vague acknowledgements such as providing editorial assistance should be avoided because they are open to a wide variety of interpretations, and the guidelines suggest wording such as We thank Dr Jane Doe who provided medical writing services on behalf of XYZ Pharmaceuticals Ltd.
The joint position statement of AMWA, EMWA and the International Society for Medical Publication Professionals gives a template disclosure: The authors thank [name and qualifications] of [company, city, country] for providing medical writing support/editorial support [specify and/or expand as appropriate], which was funded by [sponsor, city, country] in accordance with Good Publication Practice (GPP3) guidelines.
In 2010, four pharmaceutical manufacturer associations recommended, in a joint position statement on publishing clinical trial results, that medical writers be acknowledged with their affiliations, the source of funding and any other potential competing interests.
Looking back in 2015, a past AMWA president who wrote manuscripts, continuing medical education and patient education named transparency, in acknowledging that medical writers are involved, as the overarching change he had seen across that work. Another past president held that writers, who are not necessarily the author of a published manuscript, in many ways still need what Harry Hopkins, Franklin Roosevelt's assistant, called a passion for anonymity. But he counted among the most positive changes the recognition, visible in guidelines for authors, that it is important to acknowledge the contribution writers and editors make for reasons of transparency, which also means the world has taken notice of them.
Disclosing every contributor
The International Society for Medical Publication Professionals endorsed a contributorship model of disclosure, in which manuscripts submitted to biomedical journals include information about all contributors, including those who are not named authors. The model seeks to redress the lack of a universally applied standard for crediting medical writers' involvement: writers' contributions typically do not meet the ICMJE authorship criteria, but in some cases they do, such as when writers plan a data analysis or interpret study results, and not all journals have adopted the ICMJE criteria.
For everyone who assists in researching, developing or publishing a scientific paper, the society recommends compiling their full name and highest professional degree, their affiliation or employer, their specific role in the planning, conduct and analysis of the trial and in preparing the manuscript, and any compensation or consideration received and its source, and including the list with the submission cover letter. Because the model was not yet widely recognised, the society cautioned that the submission should also comply with each journal's requirements on authorship, and noted that the BMJ, which pioneered the contributorship model, asks one or more contributors to designate themselves guarantors who accept full responsibility for the paper's contents. The society asked its members to make the model a standard operating procedure and planned a consensus conference to encourage other organisations, notably biomedical publishers, to adopt it.
A journal publications director advised in 2007 that, depending on a journal's editorial policy, non-authors may be required to complete disclosure forms at some point during submission, and that the contributions of statisticians, medical writers and any other non-authors involved in data management and analysis should be acknowledged in the manuscript. In his view, a journal editor's scepticism undoubtedly rises when an industry-supported manuscript is submitted, but proactively providing clear and complete disclosure information increases transparency, which editors much prefer, and the whole process from initial editorial review through peer review to acceptance and publication will proceed more efficiently if transparency is kept high.
Acknowledging subcontracted writers
Formal guidelines on attribution, acknowledgement and authorship for professional medical writers are clear about writers' responsibilities and the need for disclosure, with the ICMJE criteria governing authorship and Good Publication Practice 3 outlining the writer's role in industry-funded research. Applying them can be challenging, especially where writing is subcontracted or delegated to freelance writers not directly employed by a medical communications agency, because criteria for who to acknowledge, and how, are lacking, and as of 2020 there was no guidance on ethical publication practice for subcontractors and no industry code of conduct for subcontracted medical writing services. The conventional practice names the professional medical writer, the organisation that employs them and the source of funding in the acknowledgements, which aims to avoid accusations of ghostwriting, defined as the unacknowledged use of writing assistance. But what writing assistance deserves acknowledgement remains undefined, so in practice substantial support from subcontractors or freelancers may not be acknowledged, and contributions are often credited exclusively to agency staff.
Earlier work gave narrow examples of contributions that would qualify a writer for acknowledgement, such as drafting the introduction and discussion sections, or developing a manuscript from a clinical trial report written by another writer with substantial input from the authors but without performing a literature review or elaborating on the discussion. A broader standard, proposed in 2020, holds that an individual professional writer should be personally acknowledged if they made a substantial contribution to drafting the outline or full first draft of a publication, or provided a substantial intellectual contribution to its development. A subcontracted or freelance writer who meets either criterion should be acknowledged with the statement "[Name of subcontracting individual] of [Contracting medical communications agency] provided professional medical writing support funded by [Sponsor]", which aims to credit the individual writer while also crediting the contracting party by naming it as the entity supplying the support.
The proposal's authors argue for personal acknowledgement from transparency about interests, from accountability and from recognition. On transparency, potential conflicts of interest are rarely discussed between subcontractors and agencies, and freelance writers sometimes work at the same time on projects for competing drugs, sometimes with the full knowledge and blessing of at least one client, whereas in an agency clients expect rigid controls between colleagues working on conflicting accounts. Acknowledging individual subcontractors would ensure public disclosure, and discoverability, of potential competing interests.
On accountability, the ICMJE recommends seeking written permission before anyone is acknowledged, because acknowledgement implies endorsement of a manuscript's content and of the policies and procedures followed in drafting it, so the ability to decline is an important mechanism for self-regulation within the industry. Informal survey data indicate that only 3% of professional medical writers would decline acknowledgement. A subcontractor's ability to disagree with, influence or protest a client's practices is generally limited, so declining acknowledgement is one way to balance a relationship that can be one-sided in the client's favour, and subcontractors should not be forced to accept responsibility for outputs or practices they disagree with. Denying contributors the opportunity to approve a submission is a potential loophole in the ICMJE authorship criteria that could be used to avoid granting authorship inappropriately, and the same loophole applies to medical writers, especially subcontractors or freelancers who may be exploited, in that acknowledgement may be attributed disproportionately or solely to a supervising writer. The passing of time, rather than a lack of intellectual contribution, may be used to justify not contacting a subcontracted or freelance writer for permission at submission.
On recognition, writers are routinely expected to indemnify clients against errors and omissions as part of manuscript development, and in return they should have the right to claim responsibility for their work, much as an artist or photographer is credited for a commissioned piece. For many writers acknowledgement is a formal recognition of their contribution to the scientific literature and a demonstration of their skill. Efforts to assess individuals' contributions beyond authorship have continued from analyses of acknowledgements sections reported more than fifteen years before 2020 to the collation of peer-review contributions, and because acknowledgement bears on a writer's career advancement, the effect of new assessment tools must be considered.
When a client will not acknowledge the writer
That medical writing support needs to be acknowledged is almost common knowledge, yet a writer new to the profession reported difficulty in getting her writing support acknowledged. Many established writers have no problem requesting acknowledgement, but the situation might be different for someone new to medical writing who is desperately looking for work and pay to make ends meet. Developing ethical guidelines is good, but peers also need to support each other in implementing them.
Writers discussing the problem in 2021 made three recommendations:
- Even if it is hard at the beginning, it is much better to lose a customer than to engage in ghostwriting, that is, to accept that writing support is not acknowledged, since working long term with someone who does not respect a writer's contribution will not pay off.
- If a client does not want to acknowledge the support, open a discussion by asking the reason for such a violation of guidelines and common practice, having first become familiar with the ICMJE recommendations, Good Publication Practice (GPP3), EMWA's guidelines and the publications that demonstrate the value of medical writers.
- State in the contract that the writer works according to the ICMJE and GPP3 guidelines and consequently expects acknowledgement, which clarifies the situation upfront.