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Reporting Conflicts of Interest, Financial Aspects of Research, and Role of Sponsors in Funded Studies
Phil B. Fontanarosa, MD, MBA;
Annette Flanagin, RN, MA;
Catherine D. DeAngelis, MD, MPH
JAMA. 2005;294:110-111.
Research studies in biomedical journals are increasingly scrutinized, not only for their scientific findings and clinical and public health implications, but also because of concerns related to conflicts of interest of investigators1 and concerns about misleading reporting of industry-sponsored research.2 The perception that conflicts of interest or financial concerns may have potentially detrimental effects on medical science has prompted medical journals to critically examine and more vigorously enforce policies for disclosure of potential conflicts and for reporting of relationships with industry.3
The need for transparency in reporting the financial conflicts of interest of authors and the relationships between investigators and funding sources has never been greater and is essential to help maintain confidence and trust in the scientific integrity of medical research articles. In this editorial, we review and update our policies for authors reporting conflicts of interest and disclosing financial support and other paid contributions for their work, as well as the requirements for reporting of industry-sponsored studies. Much of this information and the rationale for these policies have been described in previous editorials4 and are detailed in the current JAMA Instructions for Authors.5
Reporting Financial Conflicts of Interest. All authors of all manuscripts submitted to JAMA (including research reports, reviews, opinion pieces, letters to the editor, and book reviews) are required to report potential conflicts of interest, including specific financial interests relevant to the subject of their manuscript. Authors are expected to provide detailed information about any relevant financial interests or financial conflicts within the past 5 years and for the foreseeable future, particularly those present at the time the research was conducted or the paper was written and up to the time of publication. Authors also must report other financial interests that represent potential future financial gain, such as relevant filed or pending patents or patent applications in preparation. Although many universities and other institutions and organizations have established policies and thresholds for reporting financial interests and other conflicts of interest, JAMA requires complete disclosure of all relevant financial relationships and potential financial conflicts of interest, regardless of amount or value. Authors who are uncertain about what might constitute a potential financial conflict of interest should always err on the side of full disclosure and should contact the editorial office if they have questions or concerns.
To report this information, each author is required to sign and submit the following disclosure statement on the JAMA authorship form: "I certify that all my affiliations with or financial involvement, within the past 5 years and foreseeable future (eg, employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, royalties) with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript are completely disclosed."5 Authors may include these disclosures on the JAMA financial disclosure form or should indicate that the disclosures are included in an attachment to the form or in the manuscript. In addition, authors who have no relevant financial interests should provide a statement indicating that they have no financial interests related to the material in the manuscript. Authors will be reminded to report this information at the time they submit their manuscript via our online manuscript submission and review system.5
For all accepted manuscripts, each author’s disclosures of relevant financial interests or declarations of no relevant financial interests will be published. Decisions about whether financial information provided by authors should be published, and thereby disclosed to readers, are usually straightforward. Editors are willing to discuss disclosure of specific financial information with authors, but the JAMA policy is one of complete disclosure of all relevant financial interests.
Reporting Financial and Other Support. In addition to individual financial conflicts of interest, authors are required to report detailed information regarding all financial and material support for the research and work. This includes, but is not limited to, all grant support and funding sources, any provision of equipment and supplies, and other paid contributions. JAMA requires authors to specify the role of the funding organization or sponsor in each of the following: "design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript."5 All financial and material support should be clearly and completely reported in the "Acknowledgment" section of the manuscript, along with detailed information on the roles of each sponsor or funding source.
In addition, all individuals who provided other important paid contributions should be identified, with their names and affiliations listed in the "Acknowledgment" section of the manuscript, or as authors if they meet the full criteria for authorship.5 These contributions include the work of paid or employed writers, statisticians, epidemiologists, and others involved with data management and analyses. Manuscripts that are ghost written by industry employees or hired writers or that have other undisclosed important paid contributions should not be submitted to JAMA.
Requirements for Reporting Industry-Sponsored Studies. For all reports (regardless of funding source) containing original data, at least 1 author (eg, the principal investigator) must indicate that she or he "had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis."5 For industry-sponsored studies, this statement must be provided by an investigator (preferably the principal investigator) who is not employed by any commercial funding source. Moreover, in industry-sponsored studies, it is strongly preferred that data collection and data management are conducted independently of the study sponsor and with additional monitoring and oversight, such as under the auspices of an independent data and safety monitoring committee.
In addition, industry-sponsored studies in which the data analysis has been conducted only by statisticians employed by the company sponsoring the research will not be accepted for publication in JAMA. This does not mean that the names of industry-employed statisticians, epidemiologists, or others involved with the data management or analyses should be removed from the manuscript reporting these studies; their roles as authors or nonauthor contributors should be clearly identified. However, for these studies, an additional independent analysis of the data must be conducted by statisticians at an academic institution, such as a medical school, academic medical center, or government research institute.
For these analyses, the entire raw data set should be given to the independent biostatistician, along with the study protocol and the prespecified plan for data analysis. The independent biostatistician should verify the appropriateness of the analytic plan and conduct an independent analysis of the raw data. The results of these analyses should be reported in the manuscript. The independent statistician should clearly describe his or her involvement in conducting the analyses, and provide written confirmation of the data analysis. Details of this independent statistical analysis, as well as the name and academic institution of the independent statistician and whether compensation or funding was received for conducting the analyses, must be reported and will be included in the published article. We recognize that this requirement for an independent statistical analysis of industry-sponsored studies entails additional effort, time, and cost, but in our view, this additional verification of the data and the analyses, as well as an additional layer of institutional oversight for these studies, are essential.
Reporting Clinical Trials. To assist editors and reviewers in the evaluation of randomized controlled trials, JAMA requires authors to submit the CONSORT flow diagram and checklist along with the manuscript.5 Authors also are encouraged to submit study protocols at the time of manuscript submission. In addition, beginning September 13, 2005, randomized clinical trials must be registered in a publicly accessible clinical trial registry, such as clinicaltrials.gov or one that requires the minimum registration data set as determined by the World Health Organization and the International Committee of Medical Journal Editors.6-8 Authors should indicate the name of the trial registry, along with the registration number/identifier and the URL that links to that registry, at the end of the abstract of the submitted manuscript.
While we recognize that these policies are not infallible, we continue to believe that more transparent reporting should help ensure the integrity of medical science; enable physicians, other health professionals, and the public to interpret the results of scientific studies appropriately; and maintain public confidence in biomedical research.
AUTHOR INFORMATION
Financial Disclosures: None reported.
Editorials represent the opinions of the authors and JAMA and not those of the American Medical Association.
Author Affiliations: Dr Fontanarosa is Executive Deputy Editor (phil.fontanarosa{at}jama-archives.org), Ms Flanagin is Managing Deputy Editor, and Dr DeAngelis is Editor-in-Chief, JAMA.
REFERENCES
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1. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA. 2003;289:454-465.
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2. Mathews AW. Worrisome ailment in medicine: misleading journal articles. Wall Street Journal. May 10, 2005:A1.
3. Davidoff F, DeAngelis CD, Drazen JM, et al. Sponsorship, authorship, and accountability. JAMA. 2001;286:1232-1234.
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4. DeAngelis CD, Fontanarosa PB, Flanagin A. Reporting financial conflicts of interest and relationships between investigators and research sponsors. JAMA. 2001;286:89-91.
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5. Instructions for Authors. JAMA. 2005;294:119-125.
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6. DeAngelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004;292:1363-1364.
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7. DeAngelis CD, Drazen JM, Frizelle FA, et al. Is this clinical trial fully registered? a statement from the International Committee of Medical Journal Editors. JAMA. 2005;293:2927-2929.
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8. International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication. 2005. Available at: http://www.icmje.org. Accessed June 10, 2005.
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