International Society for Medical Publication Professionals – Good Publication Practices Guidelines Released

The International Society for Medical Publication Professionals (ISMPP) recently published a revised Good Publication Practice document known as “GPP2,” which was developed in a Steering Committee, and independently peer reviewed and published in the British Medical Journal (BMJ). The goal of GPP2 was to address legislative, guidance, and ethical developments since 2003, and to reinforce the aims of the original document. The good practice publications guidelines were also updated in response to changes in the environment in which authors, presenters, and other contributors work together to communicate medical research. ISMPP noted that these guidelines apply to peer reviewed jour­nal articles and presentations at scientific congresses.

 

The new guidelines address how medical research is often the “product of collaborations with other individuals (such as clinical investigators, biostatisticians, and professional medical writers) from around the world.” Sometimes, these individuals work for pharmaceutical and drug companies. As a result, ISMPP recommends that companies describe obligations for good publication practice in written publication agreements with authors of articles or presentations and with members of writing groups or publication steering committees. ISMPP also recommends that authors:

 

· Avoid premature publication or duplicate publication;

· Disclose potential conflicts of interest in all articles and presentations;

· Identify funding sources in all articles and presentations including all significant contributions made by individuals and organizations;

· Ensure authorship is attributed appropriately; and

· Provide the sponsor with copies of publication policies from the authors’ institutions

 

ISMPP also recommends that the written agreement confirms the shared responsibilities of all contributors, including authors and sponsors, and that it:

 

· Confirms that sponsors will work with clinical investigators, authors, and contributors to report and publish studies in a timely and responsible manner;

· Defines the criteria that will be used to determine authorship for articles and presentations; and

· Provides protection to parties with intellectual property rights, and establishes a reasonable period before study results are made public for intellectual property rights to be protected

 

The new guidelines also recommend that written agreements for articles and presentations from research studies are made at the earliest opportunity—for example, when the protocol is finalized.

 

ISMPP noted that it may be appropriate for companies to reimburse rea­sonable out of pocket expenses (for example, travel expenses) incurred by contributors or pay for specialized services such as statistical analysis. As a result, the details of this reimbursement must be disclosed. Also, they recommend that no honorariums are paid for authorship of peer reviewed articles or presentations.

GPP2 also recommends using criteria to determine which of the contributors to an article or presentation should be identified as authors. Specifically, they believe the criteria for authorship described in the International Committee of Medical Journal Editors (ICMJE) uniform requirements. The new guidelines acknowledge that ICMJE criteria allow assignment of authorship to individuals who have contributed to the analysis and interpreta­tion of a study but who may not have contributed to its conception and design.

 

The new guidelines also discuss using a “contributorship model” to remove ambiguity by describing what individuals participated in an article or presentation, and what their role was. ISMPP states that individual contributions to an article or presenta­tion that should be acknowledged include study con­ception and design, conceiving the idea for an article, conducting or managing a study, collecting data, per­forming statistical analysis, interpreting data, analyzing published literature, drafting a manuscript, critically reviewing a manuscript, and approving a manuscript.

 

There are also new guidelines for presentations that include an acknowledgment, even if not requested by the journal or congress, to describe:

 

· Author contributions;

· Contributions to the article or presentation from people who are not listed as authors;

· The role of the sponsor in the study and its reporting; and

· Funding sources, if any, for the research and for the article or presentation, such as for the work of a professional medical writer.

 

With regards to professional medical writers, GPP2 recommends that they should ensure that authors control and direct writing and that disclosures of funding, potential conflicts of interest, and acknowledgment of contributions are made. They clearly state that “professional medical writers are not ghostwriters,” and they even cite the Association of American Medical Colleges stating that “transparent writing collaboration with attribution between academic and industry investigators, medical writers and/or technical experts is not ghostwrit­ing.” Consequently, ISMPP does recommend that authors and professional medical writers working with authors use a published checklist to discourage ghostwriting.

 

The new guidelines suggest that 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, so that the authors can 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. GPP2 does allow authors to delegate to the medical writer (or to an assistant) the administrative tasks associated with submitting the article or presentation to a journal or congress.

 

GPP2 recommends that authors disclose financial rela­tionships and non-financial relationships that could be seen as inappropriately influence or seem to influence professional judgment. They ask for these dis­closures in all articles submitted for publica­tion in peer reviewed journals, as well as in abstracts and posters submitted to congresses at the time of submission, if space requirements allow, and that they are included in oral presentations and posters at the time of presentation, regardless of whether disclosure is requested by the journal or congress.

 

ISMPP does state however that presently there is no universal standard applied by journals and congresses for disclosure of potential conflicts of interest. As a result, they recommend favoring greater, rather than lesser, disclosure. They also recommend that  companies, and the organizations or individuals working for them, document how pub­lications are initiated and developed. ISMPP wants documentation to be including:

 

· Agreements to participate in the writing process (for example, signed and dated letter, email)

· Details of intellectual input, direction, and contributions, including comments on drafts (emails, notes from teleconferences) or drafts that contain revisions

· Main versions of the draft, to document how comments on previous versions were incorporated

· Workflow and timelines that were used to develop the document, including time taken to review and revise the document

· Approval from authors of the final version to be submitted

· Lists of participants other than authors who were allowed to review or comment on the document.

 

This update for publication guidelines will serve as a useful reference to researchers and authors for numerous medical journals and presentations.