Sponsoring agencies (e.g., pharmaceutical, device, or equipment firms; contract research organizations; or academic entities) are involved primarily in the following aspects of the publication process:
Communication between the investigators and the study sponsor, as between the authors and the journal, is crucial to ensuring that the sponsor's role is properly defined and fulfilled. For manuscripts that identify the contributions of a sponsor, the publisher may request the name and contact information of a sponsor representative to serve as a corresponding agent. This representative may be a third party (i.e., not directly employed by the sponsor but acting in an agent capacity).
Manuscripts reporting the results of a sponsored study may include one or more of the sponsor's employees or consultants as authors. These authors are bound to the authorship requirements set forth by the publishing journal. For biomedical journals, these requirements are often based on the International Committee of Medical Journal Editors (ICMJE) Uniform Requirements for authorship.86 In particular, all listed authors must make significant intellectual contributions to the manuscript. It is inappropriate for the sponsoring organization to offer guest or "courtesy" authorship, which is defined as the inclusion on the author byline of an individual who does not meet the criteria for authorship.
Ghost authorship is also inappropriate. The World Association of Medical Editors (WAME)87 defines ghost authorship as any substantial contribution to the writing of a manuscript by an individual whose role is not disclosed in the manuscript. Unattributed contributions to data analysis may also constitute ghost authorship. If a medical writer contributes to a manuscript, sponsors should consult the authorship guidelines of the publishing journal, the ICMJE,86 the European Medical Writers Association (EMWA),88 and the American Medical Writers Association (AMWA)89 to determine whether the contribution qualifies the medical writer for authorship.
Journal editors typically require corresponding authors to be forthright about all contributors and to comply with the journal's criteria for authorship. If a writer does not meet authorship criteria, he or she may meet the journal's criteria for acknowledgment. In such cases, the journal may ask the publication's authors to obtain a signed statement from all acknowledged contributors detailing their contributions. Journals may also ask for disclosure of conflicts of interest from acknowledged contributors. (See section 2.2 for more information on authorship.)
Authorial independence from undue sponsor influence is essential. In the course of executing usual authorship forms, editors and publishers may require authors to state that they submit the manuscript of their own free will, without undue influence from the sponsor. Authors may be required to state that they agree with the interpretation of the results and the conclusion as stated in the manuscript. Whatever their relationship with the sponsor, authors must ensure that the results and their interpretation as presented in the submitted manuscript are based solely on scientific criteria (regardless of the outcome). Additionally, the authors should be free to submit the manuscript to the journal they consider most appropriate.
Sponsors should be transparent in disclosing financial or in-kind support provided to authors and/or guest editors. Similarly, authors and/or guest editors must disclose all financial or in-kind support received from the sponsors and disclose current relationships with the study's funding source(s). The sponsor's relationship with the authors should be clearly and fully stated in the conflict of interest disclosure signed by the authors and should mention all support given by the sponsor, including the provision of research materials, employment, honoraria, grants, and all other types of material and financial support. Editors may also ask that the sponsor's specific role in manuscript development be declared (i.e., the role of sponsor in research design, data collection/analysis, decision to publish, choice of journal, etc.). If the sponsor played no such roles in the study, this should also be stated (see the ICMJE authorship requirements86 for more details).
To protect the integrity of published results, all study investigators and manuscript authors should have access to the full study data set and the right to use all study data for publication. Editors and publishers may require sponsors to warrant that all authors of the submitted manuscript have full access to the data and results reported, and/or require that authors acknowledge that they have been granted full data access. If asked, sponsors of research should provide investigators and journals with clearly outlined policies for sharing data and materials, including providing information to repositories. Sponsors should be prepared to cooperate with authors in fulfilling journal requests for data. Some journals may require registration of phase 3 clinical trials. Although some registries do not specify whose responsibility it is to register a clinical trial, it may be the sponsor's responsibility (See section 2.4.7), the author's responsibility (see section 2.2.6), or both (see also the Council of Science Editors endorsement of the ICMJE's statement on clinical trial registration90). Sponsors and investigators should avoid entering into agreements that limit the sharing of data and materials supporting their published claims. Sponsors should be aware that many journals have policies requiring the sharing of data and materials from an accepted manuscript. Authors should be able to remove their names from a manuscript if they are not given complete access to data.
Sponsors who claim ownership to the data being reported, along with the manuscript's authors, will be asked to sign over certain publication rights to the journal through copyright transfer or a licensing agreement. Sponsors should be aware of, and must abide by, the terms of these agreements. Resubmission of substantially similar results to another journal, under the direction or influence of the sponsor, may require permission of the copyright holder. Sponsors must avoid duplicate and redundant publication of primary study results. Secondary publications resulting from a study should cite the primary publication and should be different enough to warrant a secondary publication.
Proper sponsor conduct and ethical practices include, but are not limited to:
Sponsor misconduct or engagement in unethical practices may be grounds for a journal correction or retraction if such action is deemed appropriate by the journal's editor after a complete and fair investigation (see section 3.0).
Trial sponsors are required under United States law to register trials and to report the findings as defined within Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA).91 The sponsor, along with the trial investigators and publishing journal, should ensure that the appropriate acknowledgments and disclosures include the publicly accessible registration number for each trial submitted for publication. Click here for examples of editorial letters related to this topic (refer to letters 10 and 14-17).
(Authorship: Michael Kahn and Heather Goodell took the lead in writing this section of the white paper on behalf of the CSE Editorial Policy Committee. Michael Kahn, Heather Goodell, and Gene Snyder revised this section for the 2009 Update. Members of the Editorial Policy Committee and the CSE Board of Directors reviewed and commented on it. This section was formally approved by the CSE Board of Directors on March 29, 2009.)
American Medical Writers Association (AMWA). Position statement on the contribution of medical writers to scientific publications. Available at: http://www.amwa.org/default.asp?Mode=DirectoryDisplay&id=308 (Accessed January 20, 2011).
International Committee of Medical Journal Editors (ICMJE). Uniform requirements for manuscripts submitted to biomedical journals. Available at: http://www.icmje.org/ (Accessed January 20, 2011).
Jacobs A, Wager E. European Medical Writers Association (EMWA) Guidelines on the role of medical writers in developing peer-reviewed publications. Curr Med Res Opin. 2005;21:317-321. Available at: http://www.emwa.org/Mum/EMWAguidelines.pdf (Accessed January 20, 2011).
World Association of Medical Editors (WAME). Ghost writing initiated by commercial companies. Available at: http://www.wame.org/wamestmt.htm#ghost (Accessed January 20, 2011).