Access to Data Statement - AMA Manual of Style

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Access to Data Statement 

Access to Data Statement

Chapter:
Ethical and Legal Considerations
Author(s):

Annette Flanagin

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Subscriber: null; date: 04 May 2016

Access to Data Statement

UPDATE: The requirement for independent statistical analysis in industry-sponsored or industry-analyzed studies published in JAMA has been discontinued. This change was made July 10, 2013.

The ICMJE recommends that editors request authors of studies funded by companies or agencies with proprietary or financial interests in the study outcomes to sign a statement indicating that they had access to all of the data and can vouch for the integrity of the data analyses.7 For example, for all reports containing original data, JAMA and some of the Archives Journals require at least 1 author (eg, the principal investigator) who is independent of any commercial funder to 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.”10,11

JAMA publishes such an access to data statement in the Acknowledgment section. (See also 5.5.4, Conflicts of Interest, Access to Data Requirement.)

For industry-sponsored studies and any other studies in which proprietary concerns could lead to bias in the analysis, the data analysis should be conducted by an independent statistician at an academic institution, such as a medical school, academic medical center, or government research institute, that has oversight over the person conducting the analysis and that is independent of the commercial sponsor rather than only by statisticians employed by the sponsor of the research. For example, for manuscripts in which the statistical analysis was performed exclusively by employees of the commercial sponsor, JAMA editors will ask the authors to have the analysis and results verified by an independent statistician at an academic institution; ask that statistician to provide a statement that he or she had access to all the data (entire raw data set, study protocol, and prespecified plan for data analysis) and has independently verified the analysis and results; and publish a notice of this independent verification in the Acknowledgment section along with information on funding for this additional analysis.9 (See also 5.5.5, Conflicts of Interest, Requirements for Reporting Industry-Sponsored Studies.) See the examples below.

Independent Statistical Analysis: The accuracy of the data analysis was independently verified by Jasmine Singh, PhD, and Frank Martin, PhD, both from the Experimental Research Foundation, an affiliate of Columbia University, who received the entire raw database and replicated all the analyses that were reported in the accepted manuscript. No discrepancies were discovered. Neither Dr Singh or Martin nor the Experimental Research Foundation received any funding for this independent analysis.

Independent Statistical Analysis: Data sets for the interim analyses were forwarded by Labyx Biometrics Inc to an independent statistician, Paul Wise, PhD, of the Medical Research Unit, University of Reading, Reading, England. Dr Wise, who had no involvement in the planning and conduct of the original analyses, conducted an independent analysis of the data and has verified that the results presented in this publication are consistent with his analysis. Dr Wise was compensated for this analysis by the sponsor of the study.

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