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Editorial Commentary on Scientific Fraud

From the Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama.

Correspondence: Address correspondence to: Kirby I. Bland, MD, Department of Surgery, University of Alabama at Birmingham, 1808 7th Ave. South, Room 502BB, Birmingham, AL 35233; Fax: 205-975-2199; E-mail: kirby.bland@ ccc.uab.edu.

The Editorial Board of the Annals of Surgical Oncology has always functioned within a "system of integrity" where authors have submitted papers with the duty and obligation to ensure that the contents of the manuscript are truly original and authentic. The article on "Scientific Data from Clinical Trials: Investigators’ Responsibilities and Rights," concurrently published in the Annals, lists the ethical requirements recently adopted as policy by the editors of 13 biomedical journals, including leading American and British surgical journals. These journal editors strongly oppose inappropriate or restrictive research contracts. They insist that scientific investigators assume adequate responsibility for the conduct of all clinical trials; that they be granted sufficient access to the data to perform all necessary, comprehensive, scientific, and statistical analysis; and that authors should have control of the decisions relating to the publication process of when and where to publish the results of clinical trials. The Editors of the Annals of Surgical Oncology support and endorse all of these tenets.

It is reassuring to know that the editors of these biomedical journals for surgical science have expressed concern over issues of egregious scientific impropriety. The policy endorsed by the editors will "routinely require authors to disclose details of their own and the sponsors’ role in the study." Furthermore, the editors will "ask the responsible author to sign a statement indicating that he/she accepts full responsibility for conduct of the trial, had access to the data, and controlled the decision to publish." And finally, the editors "will not review or publish articles based on studies that are conducted under conditions that allow the sponsor to have sole control of the data or to withhold publication." ¹ These guidelines underscore the importance of establishing integrity in research and credibility in publication. By these means, the readership is assured that it is the authors who are directly responsible for the methods, materials, and results of their work; that the authors have not entered into binding agreements with industry sponsors, governmental or nongovernmental support groups, or other funding agencies; that the authors have allowed no external consideration to interfere with access to the scientific data; and that the authors consider their primary ethical obligation to hold themselves responsible for data analysis independent of the sponsor.

As biomedical scientists are solely responsible for the integrity of their data, no sponsor of biomedical research should have the opportunity to be involved in the preparation of the written manuscript or to influence the audience or journal in which the data is published. It is clear, however, and the editorial policy explicitly states, that authors should acknowledge the role of the study’s sponsor(s) if these funding agencies are in any way involved in the study design. Indeed, sponsors may legitimately support or initiate a research hypothesis. However, authors should provide full disclosure of the role of the sponsor in the "collection, analysis, and interpretation" of the outcome data. This open and unrestrictive policy ostensibly removes the industry sponsor from influencing the data analysis regardless of the research hypothesis that may be supported by the sponsor.

The initiators of clinical research trials have the obligation to protect the integrity of research and the accuracy of the data and its statistical analysis. The new editorial guidelines acknowledge this ultimate responsibility by encouraging trial sponsors to make their written protocols and/or contracts associated with the research projects available to the editors before a decision for publication. However, the guidelines go further than this as well. The biomedical journal editors have expressed a clear reluctance to consider publishing an article if any sponsor egregiously violates these tenets, such as the authors’ prerogative to publish in journals of their own choosing.

The editorial staff of the Annals has clearly articulated the processes and criteria for management of alleged improprieties regarding industry-sponsored clinical trials. First, a review committee consisting of the Annals’ leadership (Editor, Senior Editor, Managing Editor, and Associate Editor) together with the President of the Society of Surgical Oncology, will review all material facts before making a final recommendation to the Editor. The penalty for an impropriety, e.g., attempt to control scientific data, its acquisition, interpretation, results, or how it is published, will be proportional and appropriate to the level of policy violation. It is for the Editor to make this determination and to implement the policy.

In conclusion, it is most gratifying to observe that the Editorial Board of the Annals of Surgical Oncology understands, acknowledges, and stands behind this recent move by 13 clinical and research journals to develop methods to adjudicate potential conflicts of interest in research projects. It is critical to the health of the Society of Surgical Oncology that honest research and reporting be conducted. The Editors take their responsibilities in these matters very seriously. They are hopeful that, with these measures clearly articulated for our societal membership to heed, punitive action will not be required to address violations of the statutes of integrity in the conduct of scientific research relating to the rights and responsibilities of investigators.

SUGGESTED READING LIST

Rutherford RB, Johnston KW. Potential problems with industry-supported research. J Vasc Surg 2000;31:1066–76.

Weatherall D. Academia and industry: increasingly uneasy bedfellows. Lancet 2000;355:1574.

Bodenheimer T. Uneasy alliance: clinical investigators and the pharmaceutical industry. N Engl J Med2000;342:1539–44.

Hailey D. Scientific harassment by pharmaceutical companies: time to stop. CMAJ 2000;162:212–3.

Rutherford RB, Johnston KW. Protecting the rights of investigators in industry supported clinical research. J Vasc Surg (in press).

Received for publication April 8, 2002. Accepted for publication April 22, 2002.

REFERENCES

1. Davidoff F, DeAngelis CD, Drazen JM, et al. Sponsorship, authorship, and accountability. N Engl J Med 2001; 345: 825–6.[Free Full Text]

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