Webeditorial 2

INCREASING AUTHOR DISCLOSURE REQUIREMENTS: WHAT DOES THIS MEAN FOR MEDICAL WRITERS INVOLVED IN THE MANUSCRIPT DEVELOPMENT PROCESS?

Leyna Prince (Medicus International), January 2010

In recent years, a greater number of peer-reviewed journals, across almost all therapy areas, have added to their author guidelines, or their submission systems, the requirement to not only disclose all potential financial conflicts for all named authors, but also to detail the contributions made by each author to study design and conduct, and manuscript development and approval.

Currently, requirements differ greatly from journal to journal, as does policy on whether or not the information provided will in fact be published with the article. It is well known among authors, medical writers and pharmaceutical companies that, for the most part, the higher tier journals in almost every category have more stringent requirements than low-tier journals.

However, with the recent release by the International Committee of Medical Journal Editors (ICMJE) of a standardized financial disclosure form ‘The ICMJE Uniform Disclosure Form for Potential Conflicts of Interest’ (http://www.icmje.org/coi_disclosure.pdf), and the publication of the Good Publications Practice 2 (GPP2) guidelines (http://www.gpp-guidelines.org/GPP2.pdf), in which authorship, medical writing assistance and financial disclosure recommendations feature prominently, we are likely to see a shift in submission requirements over the next 12 months, particularly amongst mid- to low-tier journals, who have been slower in the ‘take up’ of these recommendations than their high-tier counterparts.

Financial disclosure

With regards to conflict of interest disclosure, the majority of journals simply request that a statement detailing any potential conflicts be provided within the article, cover letter or the submission system, with examples often provided of types of relationships and activities that may construe a conflict. The provision of a form is not commonplace, and the requirement for information on potential conflicts that may exist through family members or friends is rare. The ICMJE form not only provides an exhaustive list of types of relationship and activity that should be disclosed (Box 1), but also requests information regarding any monies paid to a spouse as a consequence of one of the relationships or activities listed. Along with the recommendations of the GPP2, and the release and, hopefully, increased use of the ICMJE form, we should see increased transparency, and unbiased reporting, continue to improve.

Box 1. Types of relevant financial relationship listed within the ICMJE Uniform Disclosure Form for Potential Conflicts of Interest
  • Board membership
  • Consultancy
  • Employment
  • Expert testimony
  • Gifts
  • Grants/grants pending
  • Honoraria
  • Payment for manuscript preparation
  • Patents (planned, pending or issued)
  • Royalties
  • Payment for development of educational presentations including service on speakers' bureaus
  • Stock/stock options
  • Travel/accommodations expenses covered or reimbursed
  • Other (err on the side of full disclosure)

Further, the ICMJE form also requires the disclosure of any financial support received for manuscript development (Box 2), including acknowledgement of any medical writing assistance received. The inclusion of medical writing assistance in support list will be a move welcomed by many organisations, as increased acknowledgement of writing assistance by authors and sponsoring pharmaceutical companies will help to put an end to what we do being described as ghostwriting.

Box 2. Types of financial support the manuscript may have received, as requested within the ICMJE Uniform Disclosure Form for Potential Conflicts of Interest
  • Grant
  • Consulting fee or honorarium
  • Support for travel to meetings for the study or otherwise
  • Fees for participation in review activities such as data monitoring boards, statistical
  • analysis, end point committees, and the like
  • Payment for writing or reviewing the manuscript
  • Support in kind such as writing, provision of medicines or equipment, or administrative support
  • Other

Authorship

The vast majority of peer-reviewed journals have adopted the ICMJE criteria for authorship:

Authorship credit should be based on 1) substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.” [Full ICMJE Uniform Requirments for Manuscripts: http://www.icmje.org/urm_full.pdf]

Although the ICMJE does not currently provide a standard author contributions form to its member journals, the provision of the above statement has enabled journals adopting the ICMJE guidelines to stipulate that each author must detail in a statement, usually inserted into the manuscript, how they have met each of the 3 conditions.

As journal editors increasingly focus on ensuring that all named authors do in fact qualify for authorship, there has also been a recent move to confirm that all individuals named in the acknowledgements section of an article do indeed belong there, and do not qualify for full authorship. A minority of journals have started to request details of contributions made by these individuals, and, in some cases, their financial disclosure information as well.

How will the increased demand for detailed financial disclosure and author contribution statements affect the medical writer?

In the current climate, it is becoming increasingly important that medical writers actively engage all authors from the earliest possible stage of manuscript development, encouraging peer-to-peer discussion throughout. Discussion is best done in teleconference or face-to-face meetings, rather than the more traditional approach of email correspondence only. Further, in light of the new GPP2 guidelines, medical writers need to ensure that all of the authors involved in a manuscript can, without any doubt, state they have critically reviewed the manuscript at every stage of development; for example, ‘no comment’ responses at each round of review should be discouraged, and a greater effort to stimulate discussion with author should be made.

The recently released GGP2 guidelines state the following:

Professional medical writers must be directed by the lead author from the earliest possible stage (for example, when the outline is written), and all authors must be aware of the medical writer’s involvement. The medical writer should remain in frequent contact with the authors throughout development of the article or presentation. The authors must critically review and comment on the outline and drafts, approve the final version of the article or presentation before it is submitted to the journal or congress, approve changes made during the peer review process, and approve the final version before it is published or accepted for presentation.”

Finally, not only do medical writers need to ensure that the authors we assist fulfil the conditions of authorship as laid down by the ICMJE, but we also need to ensure that any conflicts of interest, as well as the provision of writing assistance, and when relevant, its funding, is fully disclosed at the time of submission, in line with the GPP2, ICMJE and EMWA guidelines.