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Contents

Requirements for Authors 

Chapter:
Ethical and Legal Considerations
Author(s):

Annette Flanagin

Requirements for Authors

UPDATE: A number of journals have clarified policies for disclosing and managing authors’ conflicts of interests, including changes to definitions and terms of what should be disclosed. The subsection on Requirements for Authors in 5.5.1 has been revised to address these changes. This update was implemented in March 2015.

Authors should disclose all relevant conflicts of interest in their work at the time of manuscript submission in the manuscript (if so required by the journal) or in a cover letter to the editor or on the journal’s disclosure form (if the journal uses one). Journals should define conflicts of interest and the types of disclosures required (eg, all types of conflicts of interest or only financial interests) in their instructions for authors and in any disclosure forms. For example, JAMA and the JAMA Network specialty journals require authors to include all relevant financial interests, activities, relationships, and affiliations (other than those affiliations listed in the title page of the manuscript) in the Acknowledgment section of the manuscript.4,20,21 The journals describe these policies in their instructions for authors and in the online manuscript submission forms. Since these disclosures are part of the manuscript, peer reviewers will see these when they review for these journals.

Some journals require authors to provide disclosure statements in a cover letter or journal disclosure form and do not share these disclosures with peer reviewers, unless the journal routinely shares author correspondence and submission forms with peer reviewers. Whether a journal requires complete disclosure of financial conflicts of interest or both financial and nonfinancial conflicts of interest and whether the disclosures are to be nonconfidential and included in the manuscript or confidential and listed only in documents and communications not shared with peer reviewers, these policies should be made clear to all prospective authors and reviewers and be publicly available in easily accessible instructions for authors. However, if a manuscript is accepted, whether the journal’s disclosure policy is nonconfidential or confidential during the review process, the author’s relevant conflicts of interest should be published.

For example, at the time a revision is requested, and before acceptance, JAMA and JAMA Ophthalmology require authors to complete and submit the ICMJE universal disclosure form; the other JAMA Network specialty journals require authors to complete a Conflict of Interest Disclosure section of the authorship form. JAMA and the JAMA Network journals do not publish these forms, but do require all disclosures to be included in the Acknowledgment section of the manuscript and for accepted manuscripts; these journals publish disclosures in the Article Information section at the end of the article. Some journals that require the ICMJE disclosure from publish these as online attachments to articles and may not include the disclosures in the actual articles.

JAMA and the JAMA Network Journals also require all authors to report detailed information regarding all financial and material support for the research and work, including but not limited to grant support, funding sources, and provision of equipment and supplies (see also 5.5.3, Reporting Funding and Other Support).

Definitions and Terms of Conflict of Interest Disclosures

JAMA and the JAMA Network Journals require authors to provide detailed information about all relevant financial interests, activities, relationships, and affiliations (other than those affiliations listed in the title page of the manuscript) including, but not limited to, employment, affiliation, funding and grants received or pending, consultancies, honoraria or payment, speakers’ bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.

Following the guidelines of the ICMJE,2 the definitions and terms of such disclosures include

Any potential conflicts of interest “involving the work under consideration for publication” (during the time involving the work, from initial conception and planning to present),

Any “relevant financial activities outside the submitted work” (over the 3 years prior to submission), and

Any “other relationships or activities that readers could perceive to have influenced, or that give the appearance of potentially influencing” what is written in the submitted work (based on all relationships that were present during the 3 years prior to submission).

Authors without conflicts of interest, including relevant financial interests, activities, relationships, andall types of conflicts of interest or only affiliations, should include a statement of no such interests in the Acknowledgment section of the manuscript and in disclosure forms. JAMA notes that “failure to include this information in the manuscript may delay evaluation and review of the manuscript,” and that “authors should err on the side of full disclosure and should contact the editorial office if they have questions or concerns.”21

Although many universities and other institutions and organizations have established policies and thresholds for reporting financial interests and other conflicts of interest, JAMA and the JAMA Network Journals require complete disclosure of all relevant financial relationships and potential financial conflicts of interest, regardless of amount or value. If authors are uncertain about what might constitute a potential financial conflict of interest, they should err on the side of full disclosure and should contact the editorial office if they have questions or concerns. In addition, authors who have no relevant financial interests are asked to provide a statement indicating that they have no financial interests related to the material in the manuscript and to include this information in the Acknowledgment section of the submitted manuscript.4,21

Decisions about whether conflict of interest information provided by authors should be published, and thereby disclosed to readers, are usually straightforward. For example, authors of a manuscript about hypertension should report all financial relationships they have with all manufacturers and owners of products, devices, tests, and services used in the management of hypertension, not only those relationships with companies whose specific products, devices, tests, and services are mentioned in the manuscript. If authors are uncertain about what constitutes a relevant conflict of interest or relationship, and whether or not the journal would deem a specific conflict of interest relevant, they should contact the editorial office.

Application of Policies to Different Types of Articles

A journal’s conflict of interest policies should apply to all manuscript submissions and types of articles, including reports of research, reviews, opinion pieces (eg, editorials), letters to the editor, reviews of books and other media, and online-only comments.

Some journals might not accept manuscripts from authors with financial interest in the subject of the manuscript. For example, editors of some journals prefer that authors of some types of articles, such as editorials and other opinion pieces and reviews, not have relevant financial interests in the subject matter.22,23 Unlike scientific reports, editorials and nonsystematic reviews contain no primary data and offer an evaluation of a topic from a selection and interpretation of the literature; hence, they are more susceptible to bias, which accompanying financial disclosures do not obviate. Authors of opinion pieces and review articles are expected to provide an expert, unbiased, and authoritative perspective, which they may not be able to do if they have financial ties to products or services mentioned in the manuscript or are otherwise related (eg, within the same area, category, or topic). However, such policies may be overly restrictive and may limit the journal’s ability to publish articles from some qualified authors. Journals with concerns about the financial interests of authors of opinion pieces and review articles must balance the risk of publishing potentially biased discussion and comment against excluding potentially valuable contributions to the literature, which in some fields may be the only expert contribution available. The key is for the editor to ensure that the editorial or review is as balanced, objective, and evidence-based as possible. If, after review and careful consideration, the editor believes the work is biased and that the author is unable or unwilling to revise the manuscript to eliminate such bias and prospective readers would be misled, the editor should not accept the manuscript for publication. JAMA’s policy recognizes that conflicts of interest are common, and in some cases perhaps even helpful (for example, from a knowledgeable and critical reviewer with an opposing viewpoint). This policy favors complete disclosure from all authors over a ban of authors with conflicts of interest. However, when inviting an author to write an editorial to comment on a paper to be published, the editors will ask the prospective author to disclose any relevant conflicts of interests before writing and submitting the manuscript and consider this information carefully, in light of the potential for harm from bias vs benefit from expertise, before confirming that the author is the best available person to write the editorial.

Publishing Authors' Disclosure Statements

Information about relevant conflicts of interest can be published in the “Acknowledgment” section at the end of the article (after the list of author contributions and before information about grants and financial or material support) or on the title page of the article near the author’s affiliation. (See also 2.10.7, Manuscript Preparation, Acknowledgment Section, Financial Disclosure, and 5.2, Acknowledgments.)

The following example shows placement in the Acknowledgment section:

Author Contributions: As principal investigator, Dr Jones had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Jones, Jacques, Smith, Brown

Acquisition of data: Jones, Smith, Brown

Analysis and interpretation of data: Jones, Jacques, Smith, Brown

Drafting of the manuscript: Jones

Critical revision of the manuscript for important intellectual content: Jacques, Smith, Brown

Statistical analysis: Jacques

Obtained funding: Jones

Study supervision: Brown

Conflict of Interest Disclosures: Dr Jones has served as a paid consultant to Wyler Laboratories. Dr Jacques owns stock in Wyler Laboratories. Drs Smith and Brown reported no financial interests.

[Or: Conflict of Interest Disclosures: None reported.]

Funding/Support: This study was funded in part by Wyler Laboratories.

The following example shows placement in the author affiliation footnote on the title page/screen:

Author Affiliations: Department of Cardiology, Ambrose University Hospital, Boston, Massachusetts (Drs Jones and Smith), and Wyler Laboratories, Geneva, Switzerland (Dr Jacques and Mr Dube).

Conflict of Interest Disclosures: Dr Jones has served as a paid consultant to Wyler Laboratories. Dr Jacques owns stock in Wyler Laboratories. Drs Smith and Brown reported no financial interests.

Corresponding Author: John J. Jones, MD, Department of Cardiology, Ambrose University Hospital, 444 N State St, Boston, MA 01022 (jonesj@ambroseuniv.edu)

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