An important modification will be published in the next revision of the “Uniform Requirements for Manuscripts Submitted to Biomedical Journals”—a document to which the Journal of Vascular Surgery ascribes.
When sponsors are directly involved in research studies of drugs and devices, there is the potential that methodologic or interpretive biases may be introduced. Because the Journal of Vascular Surgery has an obligation to publish credible work, the editors will ask authors to clarify the conditions under which the research project was supported by commercial firms, private foundations, or government. This policy has been implemented by other major medical journals including Journal of the American Medical Association, New England Journal of Medicine, The Lancet, Annals of Internal Medicine, Canadian Medical Association Journal, Journal of the Norwegian Medical Association, New Zealand Medical Journal, Dutch Journal of Medicine, The Medical Journal of Australia, WJM Western Journal of Medicine (Davidoff F, DeAngelis CD, Drazen JM, Hoey J, Hojgaard L, Horton R, et al. Sponsorship, authorship, and accountability. N Engl J Med 2001;345:825).
Effectively immediately, the authors will be asked to explain their role and involvement in the study and the sponsor's role and involvement. Specifically, in the methods section, the authors should describe the roles of the study sponsor(s) and the investigator(s), in (1) study design, (2) conduct of the study, (3) data collection, (4) data analysis, (5) data interpretation, (6) writing of the report, and (7) the decision regarding where and when to submit the report for publication. If the supporting source had no significant involvement in these aspects of the study, the authors should so state. Also, if a study is funded by an agency with a proprietary or financial interest in the outcome, the editors will ask the primary responsible author to further verify this by signing the following statement: “I had full access to all of the data in this study and I take complete responsibility for the integrity of the data and the accuracy of the data analysis and for the writing of the manuscript.”
In the future, the Journal of Vascular Surgery will ask for clarification of the author(s) role(s) and may not publish papers if the responsible author(s) has (have) entered into an agreement that has limited their input into the design of the study or the conduct of the protocol, their access to original data or their ability to analyze the data independently, their preparation of the manuscripts, and the decision to publish the results in a timely fashion.
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