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Conflict of Interest Policy

Conflict of Interest Policy

Overview

The purpose of NEJM Journal Watch is to help medical professionals stay current with clinical research and standards of practice. To fulfill this mission, the editorial boards select the most important and clinically relevant medical research reports and write critical, authoritative, and timely summaries of that research, including expert commentary. In addition, NEJM Journal Watch complements the research summaries with short feature articles, summaries of clinical guidelines, brief summaries of and commentary about medical news, and selected other special articles of clinical interest.

The Massachusetts Medical Society and the Editors-in-Chief, editorial boards, and staff of NEJM Journal Watch recognize that, to fulfill our mission, we must systematically and proactively address conflicts of interest. Financial interests (specifically, ties to industry through employment, equity or stock ownership, honoraria, research grants, etc.) are the most obvious sources of potential conflict. Furthermore, that potential exists when the financial interests are held, at a minimum, by the individual or his or her spouse, committed partner, or dependent children. Conflicts can also arise from nonfinancial sources such as competing editorial responsibilities, academic or professional competition and affiliations, and personal relationships.

Together, the Massachusetts Medical Society Committee on Publications and the Editors-in-Chief of the NEJM Journal Watch editorial sections have developed the following Conflict of Interest Policy. This policy provides a framework within which the Editors-in-Chief, editorial boards, and staff can, systematically and with appropriate editorial judgment, address conflict-of-interest issues as they arise. The policy is divided into the following sections:

  1. Definition, declaration and disclosure of reportable interests
  2. Managing authors' and editors' conflicts
  3. Reporting conflicts of interest in original research
  4. Managing conflict of interest related to newsletter sponsorship
  5. Additional policies
  6. Monitoring compliance during the editorial process
  7. Procedure for changing this policy

Policy

  1. 1. Definition, declaration and disclosure of reportable interests
    1. 1.1. Definition of reportable interests
      1. For the purposes of this policy, "reportable interests" are defined to include:
      2. 1.1.1. Any of the following financial relationships with entities that provide health care products or services and which exceed $1000/per year:
        1. 1.1.1.1. Stock holdings or equity
        2. 1.1.1.2. Compensation for consulting, speaking engagements, or other services
        3. 1.1.1.3. Royalties
        4. 1.1.1.4. All forms of research support (including support from commercial entities, foundations, and government agencies)
        5. All funds received and equity held within the last year must be declared, as well as any commitments for the next year.
      3. 1.1.2. Positions of influence in companies that provide health care products or services
      4. 1.1.3. Publication-level editorial obligation (i.e., primary decision-making roles) on research journals
      5. 1.1.4. Board memberships on publications that compete with NEJM Journal Watch
      6. 1.1.5. Leadership positions in professional societies
      7. 1.1.6. Any of the above relationships on the part of an editor's spouse, committed partner, or dependent child which might pose a conflict.
      8. 1.1.7. For items 1.1.2–1.1.6, all positions held within the last year, as well as any commitments for the next year.
    2. 1.2. Declaration
      1. 1.2.1. Editors-in-Chief and editorial board members
        1. Editors-in-Chief and editorial board members must declare all their reportable interests annually and in writing via a standardized form to the Massachusetts Medical Society. Editors-in-Chief and editorial board members must further indicate which of these relationships exceed $10,000 and should be prepared to provide details of such arrangements upon request.
        2. Each Editor-in-Chief will, in addition, declare to the Massachusetts Medical Society any of the above relationships on the part of his/her spouse, committed partner, or dependent children that, in the judgment of the Editor-in-Chief, might be judged by reasonable independent parties to pose a conflict.
        3. Each board member must declare to his/her Editor-in-Chief all reportable interests on the part of his/her spouse, committed partner, or dependent child that might be judged by reasonable independent parties to pose a conflict. The Editor-in-Chief will certify to the Massachusetts Medical Society annually in writing that he/she has received this information from each board member.
      2. 1.2.2. Outside authors
        1. Prior to writing, invited authors who are not members of the editorial board (e.g., feature authors or contributing editors) will be provided with a summary of the above requirements and asked to declare in writing any conflicts that might be seen to compromise their ability to write fairly and objectively. If a conflict exists and the individual has not recused him/herself, the Editor-in-Chief will decide whether the author should proceed and, if so, what to disclose in the published work about the conflict (see Section 1.3.2.4 below).
      3. 1.3. Disclosure
        1. 1.3.1. Internal disclosure
          1. Disclosure forms will be held in confidence by the Publisher's office at the Massachusetts Medical Society and will be made available in full and in strictest confidence to the Executive Editor, Editor-in-Chief, and, where relevant, Deputy Editor of each Editorial Board. Disclosure information for Editors-in-Chief will be made available in confidence to appropriate members of the MMS Committee on Publications, senior management of the Massachusetts Medical Society Publishing Division, and the Editorial Advisory Board.
        2. 1.3.2. Public disclosure
          1. 1.3.2.1. Publication of policy
            1. This policy shall be published in its entirety on the www.jwatch.org website.
          2. 1.3.2.2. General disclosure on the publication websites
            1. Editorial board members' general conflict-of-interest information will be readily accessible from each Editor's profile page. All of the relationships outlined in section 1.1.1 will be disclosed; however, no information about the amounts of any financial relationships will be disclosed, nor will disclosure on the website extend to information about spouses, committed partners, or dependent children.
          3. 1.3.2.3. Note of disclosure in print
            1. A statement will appear in every print issue directing readers to the web for the full text of this policy and disclosure statements for all editorial board members.
          4. 1.3.2.4. Article-specific disclosure
            1. On occasion, an Editor-in-Chief may choose to let an author (either a member of the editorial board or an outside author) write an article despite having a significant conflict. In such cases, disclosure of the specific conflict must accompany the article in print and online (see Section 2.3 below).

  1. 2. Managing authors' and editors' conflicts
    1. 2.1. For standard summaries of original research articles, a board member or outside author may not write or make final editorial decisions about an article if he or she is an author of the original paper being covered.
    2. 2.2 For all other situations, management of editors' and outside authors' potential conflicts within the day-to-day editorial operations of each editorial board is based on the principle of recusal. Whenever a board member or potential outside author has a potential conflict (e.g., a financial conflict based on the relationships outlined in Section 1 or any other personal or professional relationship such as being a member of the same department as an author of an original article being summarized or in any way standing to gain from the article), he/she must advise the Editor-in-Chief of the nature of the conflict(s) and offer to recuse him/herself from writing or making final editorial decisions about an article. In addition, the following specific cases require an offer to recuse:
      1. 2.2.1 If a board member or outside author has written an editorial that accompanied an original paper in the journal of publication, he/she must offer to recuse him/herself from writing or making final editorial decisions about a corresponding summary.
      2. 2.2.2 If a board member or outside author has participated in the writing of guidelines, he/she must offer to recuse him/herself from writing or making final editorial decisions about a corresponding summary.
      3. 2.2.3 If a board member or outside author has participated in the editorial review of and/or decision to publish an original article, he/she must offer to recuse him/herself from writing or making final editorial decisions about a corresponding summary.
      4. The Editor-in-Chief will then evaluate the significance of the conflict and either accept the offer to recuse and reassign the article or direct the author to proceed. In the latter case, the Editor-in-Chief will also determine if article-specific disclosure of the conflict is required.
      5. Information about each board member's clinical and research interests, and current disclosure statements, are available on the editor profile pages of the NEJM Journal Watch website. Author disclosures at the time of publication of each article shall be made publicly available, beginning in June 2013, with the online version of the article.

  1. 3. Reporting conflicts of interest in original research
    1. Appropriate acknowledgment of conflicts of interest in the original source material is essential to the reader's full understanding and evaluation of the studies covered in NEJM Journal Watch. However, the journals surveyed differ in the amount of disclosure information they require and publish. Furthermore, as a secondary source, NEJM Journal Watch is not responsible — and does not have resources — for going beyond the disclosure policies of the primary journals covered. Recognizing these constraints, the following guidelines are applied in deciding whether and how to report conflicts revealed in the original source material.
    2. 3.1. Definition of reportable conflicts
      1. Whenever significant industry support is reported in the original article, the fact of a potential conflict should be reported in a succinct manner. In particular, conflict must be acknowledged in the following circumstances:
      2. 3.1.1. Total or substantial support of the research has been provided by a concern with a vested interest in the results (e.g., the manufacturer of a study drug or device)
      3. 3.1.2. Author(s) are employed by the pharmaceutical or device manufacturer whose product is under study
      4. 3.1.3. Author(s) have some other potential conflict that is relevant to the findings (e.g., holding a patent, compensation for promoting a drug, equity interest in a company, paid as consultants or authors for the study by a company)
      5. More limited degrees of support (e.g., donation of a drug, equipment, diagnostic tests, reagents, etc.) should also be acknowledged if the donated material is evaluated in the study and the outcome favors the manufacturer.
      6. The decision whether to report other forms of potential conflict (e.g., public or foundation funding) is left to the editorial judgment of the author and the Editor-in-Chief.
    3. 3.2. Terminology for reporting conflicts
      1. The precise wording for how a conflict is reported varies widely depending on the nature and scope of the particular conflict(s). As long as there is clear indication of the presence of a potential conflict, it is not necessary to provide details about the conflict or to list multiple conflicts (though the author may choose to do so). Examples of appropriate wording include:
        • "In this controlled, double-blind, manufacturer-sponsored study ..."
        • "In this study by researchers from the manufacturer ... "
        • "In this study by researchers including the holder of the patent on ... "
        • "Partially manufacturer-supported"
        • "Supported by the maker of [name of drug or device]" (especially suitable when reporting a comparison of therapies supported by the manufacturer of one)
        • "Government-sponsored", "publicly supported", or "supported by [name of government agency or academic/industry consortium]"
      2. Care should be taken that the wording does not cast an unfairly pejorative light on the research.
    4. 3.3. Guidelines on placement of conflict-of-interest information
      1. For summaries in the standard NEJM Journal Watch format (i.e., background / results / commentary), conflicts that are judged to be significant and noteworthy should be reported factually in the background section of the review. If the author believes that the conflict casts doubt on the study's validity or conclusion(s), the conflict should also (or instead) be noted in the commentary. For feature articles and other article formats, the author and editors should consult on how and where the conflict should be reported in the text.

  1. 4. Managing conflict of interest related to newsletter sponsorship
    1. NEJM Journal Watch is an editorially independent publication; however, distribution of some print issues and some access to our content online is sponsored by commercial entities. In exchange for offsetting the costs of production and distribution in print, the sponsor's name appears at the top of the first page, and the sponsor is allowed to insert an advertisement into the center of each sponsored copy. The printed newsletters typically have multiple sponsors in many countries; however, any given copy has only one sponsor.
    2. The potential for conflict raised by such sponsorship is managed in the following manner:
      • Sponsorship contracts stipulate that the sponsor shall have no control over the selection of editorial board members and no control over which original articles are reviewed or what is said within any summary or other article that appears in NEJM Journal Watch.
      • Editorial boards do not consider sponsorship in making editorial decisions and writing reviews.
      • A list of all commercial entities that sponsor distribution of any of the NEJM Journal Watch newsletters is maintained on www.jwatch.org.

  1. 5. Additional policies
    1. The Editor-in-Chief of any individual editorial section may implement additional policies pertaining to conflict of interest, as long as:
      • Those policies are consistent with the policies set forth in this document.
      • Those polices are published on the web page containing the editorial board's disclosure statements.

  1. 6. Monitoring compliance during the editorial process
    1. Every submission to NEJM Journal Watch is reviewed by at least two members of the Editorial Board. Each manuscript is also reviewed by Massachusetts Medical Society editorial staff who are familiar with this policy and the board members' published disclosure information. All reviewing editors will actively look for any evidence of bias when reviewing or editing each manuscript.

  1. 7. Procedure for changing this policy
    1. The Massachusetts Medical Society Committee on Publications administers changes to this policy. The NEJM Journal Watch editors and staff are responsible for communicating all substantive changes to the readership via notice published in print and online.

(Effective June 25, 2013)