Completeness of the Presentation

The IRB protocol is different from a grant application. The protocol should provide a summary of the research design, highlighting techniques used, data analysis, and statistical methods. Lengthy documents, such as Investigator’s Brochure or a grant application, should be provided as an attachment for reference purposes only, and not used as a replacement for the IRB’s required research protocol. The IRB Research Protocol templates provide section-by-section instructions for what information is needed for the IRB to complete their review expeditiously. These protocol templates can be found at