clude specific information about how each step in the study process will be accomplished (such as all the variables that will be included in the analyses, a detailed description of the approach to data analysis, the specific analyses and statistical tests that will be done, and the confounders that will be considered). In contrast with the more general description of research methods included in research proposals, research protocols include detailed specifications of research methods for all phases of the study.

Detailed documentation of research protocols, analysis decisions, and deviations from protocols is important for ensuring the integrity of the scientific process and specifically for ensuring public confidence in the integrity of VSD studies conducted by NIP-affiliated and MCO-affiliated VSD researchers. Thorough documentation and archiving of all study methods and analysis decisions can be considered the equivalent of keeping good laboratory notebooks. If an audit or a reanalysis of a study by an internal VSD researcher ever is conducted, thorough documentation of methods will insulate the original investigator from unwarranted criticism of the research methods used and aid the later researcher in conducting an audit or reanalysis. Having detailed research protocols for all VSD studies conducted by NIP-affiliated and MCO-affiliated researchers will support transparency of the VSD research program. Increasing the rigor with which such studies are documented and conducted will enhance public trust in findings from the VSD.

Recommendation 4.3: The committee recommends that detailed research protocols for each study conducted by an internal VSD researcher be developed, peer-reviewed, and archived. Each protocol should include well-specified definitions of the study population, exposures, and cases; detailed analytic plans; sample size requirements; and study timelines. Data collection forms, procedures, data and analysis files, programming code, and database versions should be documented, cataloged, and archived for a period of at least 7 years after completion of a study.


At its meetings, the committee heard requests for more information about VSD studies and the VSD data sharing program (Bernard, 2004; Fisher, 2004a). Transparency through the provision of more information can help to ease concerns about the implementation of the VSD program. The VSD is supported by public funds, and the committee finds it reasonable to expect that as much study-specific and programmatic information

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