2.4 Sponsor Roles and Responsibilities

2.4.1 Introduction

Communication among investigators, study sponsor, and medical education and communications companies, as between authors and journal, is crucial to ensure that the sponsor’s role is properly defined and exercised. For manuscripts that identify the contributions of a sponsor, the editor and/or publisher may request the name and contact information of a sponsor representative to serve as a corresponding agent, for example to resolve an issue that is best addressed by a person who is not necessarily one of the authors. This representative may be a third party (i.e., not directly employed by the sponsor, but acting in an agent capacity).

Sponsoring organizations, referred to herein as “sponsor,” (including but not limited to pharmaceutical, medical device, or biotechnology companies; contract research or manufacturing organizations; or academic or research entities) are involved primarily in the following aspects of the publication process:

  • Publication planning
  • Authorship
  • Process control (content and journal selection)
  • Disclosure of conflicts of interest
  • Access to and provision of data
  • Copyright
  • Clinical trial registration and dissemination of findings

Authors, sponsors, and medical education and communications companies share responsibility to publish medical information in the form of a peer-reviewed manuscript or presentation during a scientific conference in a responsible and ethical manner per recommendations included in the Good Publication Practices (GPP2) guidelines.1 Publication Planning

Publication planning is the process typically used by pharmaceutical, device, and biotechnology companies to coordinate the effective and timely publication of clinical study results. Ideally, a publication plan is designed and managed to support authors “in their efforts to ensure appropriate, efficient, and complete communication.”1 A sound publication plan sets milestones during manuscript preparation in accordance with clinical study progression (e.g., manuscript/abstract submission deadline), identifies topics for new publications (e.g., pooled data analyses, new subgroup analyses), and aids in avoiding duplicate and/or incomplete publications.1

Publication planning should be used as a tool to facilitate publication of scientific/clinical data following available guidelines. Publication plans should not be used to favorably influence putative markets for not-yet approved products. When publication planning involves substantial contributions of planners, writers, statisticians, and reviewers to the content of a publication, their respective roles should be disclosed in detail. Authorship

Author designations on manuscripts and other scientific presentations that report results of a sponsored study 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.2 In particular, each author listed on a publication should fulfill all of the following three requirements: “1) substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; and 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published.”1, 2

Manuscript authors should follow the ICMJE requirements for authorship and apply them consistently for the preparation of sponsored as well as unsponsored publications. Misinterpretations and misuse3 of these ICMJE requirements should be avoided. It is therefore inappropriate to offer guest or “courtesy” authorship, defined as the inclusion on the author byline of an individual who does not meet the criteria for authorship.

If an individual makes any substantial contribution to the writing of a manuscript and this role is not disclosed in the manuscript, this constitutes “ghost authorship” per the World Association of Medical Editors (WAME).4 Cases of ghost authorship by the pharmaceutical industry have been reported,5 as well as by academic institutions;6 ghost-authored publications have been published by high-impact factor journals.7 Ghost authorship is ethically unacceptable1 and may put patients’ health at risk.8 Note that, for example, unattributed contributions to data analyses 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,2 the European Medical Writers Association (EMWA),9 and the American Medical Writers Association (AMWA)10 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. A writer may not meet authorship criteria, yet 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. (Refer to Section 2.2 for more information on authorship.) Substantial contributions (e.g., collecting data, analyzing data, performing statistical analyses, drafting the manuscript, conducting critical review) of all authors listed as well of other contributors who do not meet the author requirements should be listed and disclosed in the publication.1 Process Control (Content and Journal Selection)

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 conclusions as stated in the manuscript. Whatever their relationship with the sponsor, authors must ensure that the results and their interpretation of the results 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 suitable. Disclosure of Conflicts of Interest

The ICMJE guidelines state that “all participants in the peer-review and publication process must disclose all relationships that could be viewed as potential conflicts of interest.”2Conflicts of interest include financial relationships (e.g., sponsored clinical studies) and nonfinancial relationships (e.g., authors with personal relationships) that can possibly affect professional judgment of the manuscript in question.1 Disclosure of potential conflicts of interest by all involved with publications, including abstracts and poster presentations for scientific conferences, is critical to enable a reader to assess a publication.

Sponsors should be transparent in disclosing financial or in-kind support provided to authors. Similarly, authors 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 list all support received from 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). If the sponsor played no such roles in the study, this should also be stated (refer to the ICMJE authorship requirements2 for more details and to the GPP2 guidelines1 for additional recommendations).

A recent study investigating the impact of industry-sponsored clinical trials on the impact factor and financial income of six major medical journals showed that publication of results of industry-sponsored clinical trials is correlated with increased impact factors and that income generated by reprint sales constitutes a substantial part of some top-tier medical journals’ total income.11 In this respect and to fulfill the ICMJE guidelines in regards of conflicts of interest disclosures, it is highly recommended that journals also disclose financial (e.g., projected increased income due to sales of a reprint of a sponsored publication) and nonfinancial (e.g., editorial staff with a personal relationship within the company that sponsored a given manuscript) relationships in a similar manner as authors are required to do.5, 11, 12 Access to and Provision of Data

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, have access to the full data set before author activities begin, and be given enough time to analyze and review the full data set as needed.1 Editors and publishers may require sponsors to warrant that all authors of the submitted manuscript have full access to all 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. 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 (refer to Section, the author’s responsibility (refer to Section 2.2.6), or both (refer also to the Council of Science Editors endorsement of the ICMJE’s statement on clinical trial registration13). 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. Copyright

Sponsors who claim ownership to the data being reported, along with the manuscript’s authors, may 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.

New manuscripts should not be submitted for consideration to multiple journals at the same time. 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 (e.g., translation into a different language, extensive reanalysis of the already published data).1, 2 Clinical Trial Registration and Dissemination of Findings

Clinical trial sponsors are required under United States law to register clinical trials and to report the findings as defined within Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA).14 The sponsor, along with the clinical trial investigators and publishing journal, should ensure that the appropriate acknowledgments and disclosures include the publicly accessible registration number for each clinical trial submitted for publication. Sample correspondence related to this topic is available on the CSE website.15

2.4.2 Proper Sponsor Conduct and Ethical Practices

Proper sponsor conduct and ethical practices include, but are not limited to:

  • Not unduly influencing authors regarding the selection or interpretation of results and/or the formulation of conclusions
  • Using publications (manuscripts, abstracts, posters) to communicate scientific data and observations, and balanced scientific interpretation and discussion thereof
  • Not engaging in or supporting guest and ghost authorship
  • Disclosing all financial and nonfinancial relationships that may possibly influence professional judgment of a manuscript or other scientific presentation
  • Allowing the authors to decide where to submit a manuscript
  • Not pressuring reviewers to favorably assess manuscripts supporting a sponsor’s product or device
  • Providing all data or materials to the authors and investigators in a timely manner as requested or disclose if the sponsor decides not to make all data available to the authors and investigators
  • Registering clinical trials as demanded by law

2.4.3 Concluding Remarks

Sponsor misconduct or engagement in unethical practices may be grounds for a journal correction or retraction if such actions are deemed appropriate by the journal’s editor after a complete and fair investigation (refer to Section 3.0). It is important to adhere to the detailed available guidelines1, 2, 4, 6, 10 that describe ethical practices related to the publication of sponsored research (i.e., research sponsored by the industrial sponsors and research sponsored by biomedical research centers). Engaging in unacceptable and unethical publication practices has resulted, in some cases, in severe penalties and put patients’ health at risk.8

It is therefore recommended to translate guidelines for the ethical publication of sponsored research into uniform policies, compliance of which should be controlled. Control of policy compliance could be governed by legal offices within the industry and academic research centers, and by journal editors. It is also important that authors, sponsors, peer reviewers, and editors engage frequently in informative discussions about a manuscript submitted for publication to ensure that ethical publication standards are met. Providing applicable ethical guidelines and associated information to individuals involved in the preparation of sponsored research-based publications by the industry as well as by medical research centers might also be beneficial. And most importantly, scientific publications should remain to be a medium to communicate scientific data and observations to the scientific community and the public.

2.4.4 References

  1. Graf C, Battisti WP, Bridges D, Bruce-Winkler V, Conaty JM, Ellison JM, Field EA, Gurr JA, Marx ME, Patel M, Sanes-Miller C, Yarker YE, for the International Society for Medical Publication Professionals. Good publication practice for communicating company sponsored medical research: the GPP2 guidelines. BMJ 2009;339:b4330.
  2. International Committee of Medical Journal Editors (ICMJE). Uniform requirements for manuscripts submitted to biomedical journals. II.A Authorship and contributorship. Available at: http://www.icmje.org/ethical_1author.html (Accessed March 9, 2012).
  3. Matheson A. How industry uses the ICMJE guidelines to manipulate authorship¾and how they should be revised. PLoS Med. 2011;8:e1001072. Available at:http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001072 (Accessed March 9, 2012).
  4. World Association of Medical Editors (WAME) policy statement on ghost writing initiated by commercial companies. Available at: http://www.wame.org/wamestmt.htm#ghost (Accessed March 9, 2012).
  5. Egilman DS, Druar NM. Corporate versus public interests: community responsibility to defend scientific integrity. Int. J. Occup. Environ. Health 2011;17:181-185.
  6. Lacasse JR, Leo J. Ghostwriting at elite academic medical centers in the United States. PLoS Med. 2010;7:e1000230. Available at:http://www.plosmedicine.org/article/info:doi%2F10.1371%2Fjournal.pmed.1000230 (Accessed March 9, 2012).
  7. Wislar JS, Flanagin A, Fontanarosa PB, DeAngelis CD. Honorary and ghost authorship in high impact biomedical journals: a cross sectional survey. BMJ 2011;343:d6128.
  8. Fugh-Berman AJ. The haunting of medical journals: how ghostwriting sold “HRT.” PLoS Med. 2010;7:e1000335. Available at:http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1000335 (Accessed March 9, 2012).
  9. 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 March 9, 2012).
  10. 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 March 9, 2012).
  11. Lundh A, Barbateskovic M, Hróbjartsson A, Gotzsche PC. Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue – cohort study. PLoS Med. 2010;7:e1000354. Available at: http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000354(Accessed March 9, 2012).
  12. Marcovitch H. Editors, publishers, impact factors, and reprint income. PLoS Med. 2010;7:e1000355. Available at:http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000355 (Accessed March 9, 2012).
  13. Council of Science Editors (CSE). Endorsement of principles: The ICMJE’s statement on clinical trial registration. Available at:http://www.www.councilscienceeditors.org/i4a/pages/index.cfm?pageid=3377 (Accessed March 9, 2012).
  14. Food and Drug Administration Amendments Act of 2007 (FDAAA). Available at: http://www.fda.gov/oc/initiatives/hr3580.pdf (Accessed March 9, 2012).
  15. Council of Science Editors. Sample correspondence. Available at: http://www.www.councilscienceeditors.org/i4a/pages/index.cfm?pageid=3335 (Accessed March 9, 2012).

(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. Wim D’Haeze and Michael Kahn revised this section for the 2012 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 30, 2012.)