A new JCI conflict-of-interest policy

Abstract

As stewards of the JCI, we are responsible for instituting and sustaining the highest possible standards for integrity. To this end, we have established a very specific set of guidelines for handling potential conflicts of interest — not only for authors and referees, but also for ourselves.

To be persuasive we must be believable; to be believable we must be credible; to be credible we must be truthful.

— Edward R. Murrow

In its most ideal form, academic biomedical research is a pure pursuit, stripped of political and financial motivations; indeed, medical professionals swear to help those in need without any thought for themselves. Medical publications hope to further this ideal by evaluating and publishing discoveries in order to advance science and to further the education of researchers. While the importance of this goal has never been questioned, the reality of the current day is that we live in a world of innumerable influences. One must assume these influences could compromise objectivity.

It follows that the scientific community would have increased confidence in the biomedical literature if potential conflicts were disclosed. Numerous publications have established conflict-of-interest policies for their authors, seeking integrity through transparency. Hence, disclosure of conflicts by authors has become commonplace. Admission of a potential conflict does not necessarily mean that an author or a finding is no longer credible; rather, it allows the reader to interpret the motivations and contributions of a particular author or funding source in the context of these potential conflicts. The JCI has established conflict of interest policies for authors in the past, and herein we present the latest modifications, as the editors felt that a more specific set of criteria for editors, authors, and referees was needed. After first establishing the basics of the policy, we received input and endorsement from the rest of the University of Pennsylvania–based editorial board and councilors of the ASCI.

As Arthur Caplan asks later in this issue (1), how are editors’ conflicts judged? We could find no published policies about conflict-of-interest rules for editors, even in journals where an editorial board of academics handles the manuscripts. Several have addressed editorial conflicts in a few sentences as part of the overall policy, but we are publishing what we believe to be the most specific and comprehensive set of rules for handling editorial conflicts of interest. The relationships a scientist may develop with industry may vary from those with negligible potential for a conflict to those with great potential to influence judgment, and therefore we have created a two-tiered policy for our editors. While we have focused largely on financial conflicts, we understand that other conflicts may arise; we hope that both honesty and rigorous peer review will buttress our policy.

Our goal is for authors to be confident that we will treat their manuscripts fairly and that we will not be swayed by potential conflicts of interest. We want our readers to be able to trust that the articles they are reading were chosen based solely on merit. Our journal can only be as good as our scientific integrity, and with this new policy, we hope that you agree we have established a foundation on which to build.

The conflict-of-interest policy adopted by the JCI at the time of the transition to a new a group of editors follows.

2007 JCI conflict-of-interest policy

The Journal of Clinical Investigation (JCI) and American Society for Clinical Investigation (ASCI) are dedicated to upholding the highest standards of integrity and ethical conduct in research, and in its evaluation and related communication. It is important that the editors, authors, and referees conduct themselves in accordance with stringent standards and transparent policies for addressing potential conflicts of interest. Herein, we delineate what constitutes a potential conflict of interest for the JCI as it relates to editors, authors, and referees.

Violations of these policies may incur sanctions as determined by the JCI editors.

Editorial conflicts of interest The JCI editors (Editor in Chief, Deputy Editors, Associate Editors, Senior Editors, Executive Editor, Science Editor, News and Reviews Editor) are responsible for maintaining the highest possible standards in evaluating contributions to the JCI as well as for maintaining the integrity of the journal and the ASCI. In the interest of establishing full transparency, editors are obliged to disclose any and all potential conflicts of interest to the JCI/ASCI. We have determined two tiers of potential conflict and corresponding actions to be taken. The editors will report changes to their potential conflicts as they occur. An annual formal review of all disclosures will be performed in the evaluation of compliance.

The first tier of potential conflicts for editors:

(1) Ownership. If an editor currently has direct ownership of equity in a private or public company in the health care field of $10,000 or more (including restricted stock; the market price of all options, vested or unvested; and warrants), a first-tier potential conflict must be declared. Interests held by immediate family members (spouse or children) of the editor are included. This does not apply to ownership of mutual funds, where the editor does not directly control the purchase and sale of stocks.

(2) Income. If an editor has received $10,000 or more per annum of income from any single private or public company in the health care field in the preceding calendar year, a first-tier potential conflict must be declared. This includes any and all sources of financial benefit, including, but not limited to, consultancy, speaking fees, royalties, licensing fees, retainers, salary (including deferred compensation), honoraria, service on advisory boards, and providing testimony as an expert witness. Income generated by immediate family members (spouse or children) of the editor are included.

(3) Research support. If an editor’s research was funded by $50,000 or more per annum from a private or public company in the health care field in the preceding fiscal year, including funding for personnel working within the laboratory, a first-tier potential conflict must be declared.

If an editor declares a first-tier potential conflict relating to (1), (2), or (3), this information will be posted on a page on the JCI’s website (www.jci.org). Should a manuscript be submitted with ties to one of these companies, the editor with the conflict will be required to leave the editorial board meeting when the manuscript is discussed. An editor will be considered to be in conflict if a manuscript is funded solely by an organization with which the editor has a potential conflict, regardless of whether a research institution employs the authors.

The second tier of potential conflicts for editors:

(4) Relationship with a company. If an editor had a relationship with a private or public company in the health care field wherein the editor received some compensation for services, but the total amount of income was between $1,000 and $9,999 for the preceding calendar year, a second-tier potential conflict must be disclosed. This includes, but is not limited to, any compensation as detailed above in (2).

(5) Relatives. If an editor has a close relative other than a spouse or child (sibling or parent) employed by or with a significant financial interest in a private or public company in the health care field, a second-tier potential conflict must be declared.

(6) Prospective employment. If an Editor is negotiating with, has arranged prospective employment with, or is expected to initiate a significant financial relationship as defined in (1), (2), or (3) with a private or public company in the health care field, a second-tier potential conflict must be declared.

(7) Personal. Editors will be required to declare a second-tier potential conflict if a manuscript is submitted by a close personal contact (former student, fellow or mentor, for example) or a recent collaborator (over the last 3 years). Relevant collaborations may include coauthoring a research article or serving as co-investigators on a grant.

(8) Competition. Editors will be required to declare a second-tier potential conflict if a submitted manuscript presents data that are highly relevant to a manuscript the editor has under review or in press elsewhere. Editors are prohibited from using unpublished information from the manuscripts under consideration by the JCI to further their own research, nor can they use new information gained from unpublished manuscripts for financial gain.

(9) Personal benefit. The editor must recuse himself/herself from discussion of a manuscript if he or she could benefit personally from its disposition. For example, if a manuscript is submitted describing the off-label use of a compound produced by a company for which an editor has a potential conflict, the editor must recuse himself/herself.

The second tier of potential conflicts will necessitate only internal disclosure to the editorial board. These potential conflicts will not be published, but they will be known to the JCI/ASCI staff and other JCI editors. The editor in potential conflict will not be required to leave the room during the discussion of the manuscript, but will recuse herself/himself from editorial discussion and decisions related to the manuscript.

All editors will have access to a list of the first- and second-tier potential conflicts, which will be posted in a highly visible location during editorial board meetings. The Executive Editor will be responsible for recording and updating all editorial potential conflicts. A former Editor in Chief of the JCI will review the Executive Editor’s potential conflicts.

We are aware that other potential issues may arise, and these will be evaluated by the Editor in Chief on a case-by-case basis. Any questions of potential conflict by the JCI editors not addressed above may be discussed with a Senior Editor or the Executive Editor of the JCI.

JCI editors are discouraged from serving as an editor who makes final decisions on manuscripts for other primary research journals. All such editorial duties for other journals must be approved by the Editor in Chief.

In order to avoid even the appearance of potential favoritism to institutional colleagues, manuscripts from the University of Pennsylvania will not be handled by the editorial board at large, but instead in a separate process. In these circumstances, the Executive Editor will be the only editor privy to the manuscript and, if the paper is sent for review, will work with a member of a prior editorial board to formulate a decision.

Author conflicts of interest All authors are expected to disclose financial relationships that could undermine the objectivity, integrity, or perceived value of a publication. The editors will keep the potential conflicts in mind while evaluating the manuscripts.

Authors must disclose potential conflicts as described below (these correspond to the first tier of potential conflicts defined for editors). Such potential conflicts will be published in a footnote if the manuscript is ultimately accepted. It is the responsibility of the corresponding author to gather the list of potential conflicts from each author and to communicate the list of all potential conflicts to the editors with the submission.

Potential conflicts to be disclosed by authors:

(1) Ownership. If an author currently has direct ownership of equity in a private or public company in the health care field of $10,000 or more (including restricted stock; the market price of all options, vested or unvested; and warrants), a first-tier potential conflict must be declared. Interests held by immediate family members (spouse or children) of the author are included. This does not apply to ownership of mutual funds, where the author does not directly control the purchase and sale of stocks.

(2) Income. If an author has received $10,000 or more of income per annum from any single private or public company in the health care field in the calendar year preceding the date of the original submission, a potential conflict must be declared. This includes any and all sources of financial benefit, including, but not limited to, consultancy, speaking fees, royalties, licensing fees, retainers, salary (including deferred compensation), honoraria, service on advisory boards, and providing testimony as an expert witness. Income generated by immediate family members (spouse or children) of the author are included.

(3) Research support. If an author’s research was funded by $50,000 or more per annum from a private or public company in the health care field in the fiscal year preceding the date of the original submission, including funding for personnel working within the laboratory, a potential conflict must be declared.

Any questions concerning these potential conflicts should be addressed in writing to the Executive Editor.

Referee conflicts of interest Referees should exclude themselves in cases where there is a material potential conflict of interest, financial or otherwise. We ask that referees inform the editors of any potential conflicts that might be perceived as relevant as early as possible following invitation to participate in the review, and we will determine how to proceed. Disclosing a potential conflict does not invalidate the comments of aConflict of Interest Policy referee, it simply provides the editors with additional information relevant to the review.

We ask referees to use their judgment in responding to our request for full disclosure, basing their response to the editors on the same financial criteria applied to authors and editors, as described above.

References

1. Caplan, A. 2007. Halfway there: the struggle to manage conflicts of interest. J. Clin. Invest. 117:509-510.
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