Manuscript Preparation Policy
Sufficient time is needed for the biostatistician to write or review the statistical methods and the results section of a manuscript or abstract. Whether the biostatistician writes or reviews these sections in a manuscript is determined by the level of collaboration. Thus, communication between the project investigator and the biostatistician is essential in order to meet specific deadlines. Generally two weeks are required for the biostatistician to write their section of the manuscript; however, four weeks may be needed for more complex analyses. Regardless, final versions of manuscripts and abstracts must be reviewed and approved before submission.
Occasionally there is concern about whether or not the biostatistician should be a co-author on the manuscript. It is our policy that the biostatistician (both Ph.D. and M.S.) should be listed as a co-author if there has been a scientific or an intellectual contribution to the research and not be listed in the acknowledgments. If this is going to be an issue with the project investigator, then an agreement with the biostatistician on authorship of any resulting manuscripts should be decided during the initial phases of the project.
The following definition of a scientific contribution is based on published guidelines by Robert A. Parker and Nancy G. Berman: "Criteria for Authorship for Statisticians in Medical Papers." Statistics in Medicine 17: 2289-2299 (1998). They list the following as examples of scientific contribution:
- Substantive input into the overall design of the study and protocol development, which may be thought of as "thinking through the study"
- Writing one or more sections of the research protocol or grant application (for example, data analysis and/or data management)
- Overall critical review to sharpen a grant application before submission, without major substantive changes
- Regular (ongoing) participation in study meetings with the other investigators
- Implementation of data collection and data management activities
- Advising only on specific issues when requested by the principal investigator
- Planning and directing the analyses. This is usually based on the analysis plan described in the grant but now includes exact model specification, resolution at decision points, etc.
- Preparing written material summarizing the results of the analyses for the other investigators and/or preparing formal reports
- Doing the analyses