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Contents

Funding and Role of Sponsors 

Chapter:
Ethical and Legal Considerations
Author(s):

Annette Flanagin

Funding and Role of Sponsors

UPDATE: We will discontinue using quotation marks to identify parts of an article, but retain the capitalization; eg, This is discussed in the Methods section (not the “Methods” section). This change was made February 14, 2013.

Information about funding, sponsorship, or other financial or material support should also be clearly and completely identified in the Acknowledgment section, if not already reported in the Methods section.7,9-11 For all manuscripts that are funded by commercial, governmental, or private entities, a description of the role of the sponsor(s) in the work reported and the preparation, submission, and review of the manuscript should be published as well.9,10 For example, for all funded manuscripts, including letters to the editor, JAMA and some of the Archives Journals require the corresponding author to indicate the role of the sponsor in each of the following:

Design and conduct of the study

Collection, management, analysis, and interpretation of the data

Preparation, review, or approval of the manuscript

If the sponsor had no role in the above activities, that information should be indicated. If authors are employees of a sponsor, this information should include any role of the sponsor above and beyond the contributions of the specific sponsor-employed authors. Some journals publish this information in the Methods section. JAMA and the Archives Journals publish it in the Acknowledgment section (see 5.5.1, Conflicts of Interest, Requirements for Authors, and the following examples).

Role of the Sponsor: The Centers for Disease Control and Prevention had no role in the design and conduct of the study or the collection, management, analysis, and interpretation of the data; it reviewed and approved the manuscript for submission.

Role of the Sponsor: The Deutsche Krenshilfe had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; and the preparation, review, or approval of the manuscript. Authors who are employees of Biopharm Company participated in each of these activities. The National Institutes of Health reviewed and approved the study before funding.

Role of the Sponsor: The Medicines Co and the REPLACE-2 Steering Committee designed the trial, developed the protocol, and determined the statistical analysis plan by consensus. Data were collected through an Internet-based electronic case-report form managed by Etrials. The sponsor had no access to the database or the randomization code, which were housed at Etrials and Integrated Clinical Technologies Inc, respectively, until finalization of the database. Data management and site monitoring were performed by International HealthCare. The finalized database was electronically transferred simultaneously to the Cleveland Clinic Cardiovascular Coordinating Center and to The Medicines Co, where unblinding and statistical analyses were separately performed. All analyses for scientific publication were performed by the study statistician at the Cleveland Clinic, independently from the sponsor. Dr Lincoff wrote all drafts of the manuscript and made revisions based on the comments of the study chairman, the Steering Committee, coauthors, and the trial sponsor. The study contract specified that the sponsor had the right to review all publications prior to submission and could delay submission of such publications for up to 60 days if necessary to make new patent applications, but could not mandate any revision of the manuscript or prevent submission for publication.

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