During three years of stewardship, the current editorial team has witnessed an increasing number of troublesome incidents surrounding publication. In one case, several authors of a multicenter study were unaware of the submission of their work, an omission compounded by their faked signatures in a standard submission form. In another, the published data had been already presented in a non-English publication, a fact that was not communicated to the editors. The nature of advertising in the journal also deserves scrutiny. Over the next months, the “Editor's Corner” will transmit views of members of the editorial team on ways to optimize publication in our pages.
HEPATOLOGY, as it approaches its 25th year of publication, must tackle the issue of conflict of interest more explicitly. Conflict of interest entails both academic and financial dimensions.1 In this issue, I would like to focus on financial conflicts of interest. Any reader of our pages can note the increasing role of the pharmaceutical industry in the design and performance of clinical and experimental studies in HEPATOLOGY. The industry plays a critical role in the development of new options for patients with liver disease. At the same time, as public companies, the industry is accountable to its stockholders, a goal that can ultimately collide with academic objectives. As editors, we need to provide our readers with information on potential conflicts, allowing audiences to evaluate the message of accepted manuscripts in an independent manner.
Research requires financial support, rendering the potential for conflict an inherent part of the publication process. While the interests of investigators, institutions, and industry converge at the time of publication, such interests often differ and appear contradictory. Compounding the problem, all three groups carry multiple identities. An investigator can also be a caregiver and an inventor; the institution where research is performed can be both a facilitator and a guardian; industry provides financial support while it prioritizes proprietary aspects of the research results. Editors must balance the tension surrounding disclosure at the time of submission.
What is the extent of the potential financial conflict of interest? A recent study provides a glimpse at the American academic enterprise2: 28% of investigators receive research funding from industry, while 43% receive research-related gifts; 33% of investigators have financial ties with industry sponsors; and 37% of investigators in the National Academy of Sciences have affiliations with industry. The potential for conflict is real.
When confronted with manuscripts depicting multicenter trials, the tension is particularly evident. “A submitted manuscript is the intellectual property of the authors,” states the authoritative document from leading medical editors.3 “As owners of the study database, sponsors have discretion to determine who will have access to the database,” affirms PhRMA, the organization that represents the Pharmaceutical Research and Manufacturers of America.4 Authorship responsibility immediately overlaps with financial disclosure. The potential for conflict of interest exists when the investigator has an additional relationship with the sponsor that extends beyond the research funds needed to conduct the study.
Currently, HEPATOLOGY authors sign a statement certifying “no commercial associations that might pose a conflict of interest with the submitted Article, except as disclosed on a separate attachment.” We will modify the Instructions for Authors: At the time of submission, authors will also need to fill out a disclosure form, providing explicit information on potential financial conflict of interest to the editors. As of January 2005, all manuscripts accepted in HEPATOLOGY, for both experimental and clinical studies, will include in their footnote a Disclosure statement. When nothing needs to be disclosed, it will be denoted. When the potential for financial conflict of interest exists, the editor will decide which elements of the disclosed information will be included in the footnote, highlighting the potential for conflict in areas covered by the manuscript.
Skeptics might wonder how disclosure can assure a pristine and faultless publication process. It does not. But the demand for disclosure contributes to the ethics of publication, together with submission of accurate data, honestly discussed. In fact, it is in the best interest of all parties that the printed word remains credible. At a time when an increasing number of therapeutic options are becoming available for patients with liver disease, the editors are committed to principles of transparency and full disclosure at the time of submission.